{ "source": "openFDA device/enforcement, joined to device/recall for record links", "source_url": "https://open.fda.gov/apis/device/enforcement/", "fetched_at": "2026-11-09T16:23:49.115Z", "fda_data_as_of": "2026-10-28", "window_months": 36, "window_start": "2023-11-09", "recalls": [ { "event_id": "99687", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2026-08-24", "classified": "2026-09-23", "reported": "2026-09-30", "product": "Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101 IMAGER II/5/BERN/65/038 BX5; M001314141 IMAGER II/5/H1/100/038 BX5; M001314151 IMAGER II/5/H1/100/035 BX 5; M001314301 IMAGER II/5/SIM1/65/038 BX5; M001314321 IMAGER II/5/SIM1/100/038 BX5; M001314341 IMAGER II/5/SIM2/100/038 BX5; M001314351 IMAGER II/5/SIM2/100/035 BX 5; M001314361 IMAGER II/5/SIM3/100/038 BX5; M001314521 IMAGER II/5/CHGB/65/038 BX5; M001314581 IMAGER II/5/CONTRA 2/65/038 BX5; M001314621 IMAGER II/5/C1/65/038 BX5; M001314661 00AGER II/5/C2/65/038 BX5; M001314671 IMAGER II/5/C2/65/035 BX 5; M001314761 IMAGER II/5/MIK/65/038 BX5; M001314771 IMAGER II/5/MIK/65/035 BX 5; M001314821 IMAGER II/5/SHK1.0/65/038 BX5; M001314861 IMAGER II/5/RC2/65/038 BX5; M001314881 IMAGER II/5/RDC/65/038 BX5", "products": 1, "reason": "Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.", "recall_numbers": [ "Z-3214-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222200" }, { "event_id": "99626", "slug": "medtronic", "firm": "Given Imaging Ltd.", "class": "Class I", "initiated": "2026-08-06", "classified": "2026-09-10", "reported": "2026-09-16", "product": "Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus.", "products": 1, "reason": "Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.", "recall_numbers": [ "Z-3090-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222013" }, { "event_id": "99454", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2026-07-09", "classified": "2026-08-20", "reported": "2026-08-26", "product": "Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter", "products": 2, "reason": "Potential for arterial sheath tip separation or partial tip separation during use.", "recall_numbers": [ "Z-2977-2026", "Z-2978-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221593" }, { "event_id": "98974", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class I", "initiated": "2026-06-17", "classified": "2026-08-05", "reported": "2026-08-12", "product": "INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.", "products": 1, "reason": "Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.", "recall_numbers": [ "Z-2879-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220311" }, { "event_id": "99031", "slug": "medtronic", "firm": "Medtronic Heart Valves Division", "class": "Class I", "initiated": "2026-05-22", "classified": "2026-07-02", "reported": "2026-07-08", "product": "Medtronic Harmony Delivery Catheter System", "products": 1, "reason": "Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.", "recall_numbers": [ "Z-2624-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220767" }, { "event_id": "98615", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2026-03-19", "classified": "2026-04-24", "reported": "2026-05-06", "product": "Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.", "products": 2, "reason": "Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE\" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: \" Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block \" VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm \" Low cardiac output or congestive heart failure secondary to bradycardia", "recall_numbers": [ "Z-1770-2026", "Z-1771-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219239" }, { "event_id": "98464", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class I", "initiated": "2026-02-13", "classified": "2026-03-26", "reported": "2026-04-01", "product": "CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D", "products": 5, "reason": "16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.", "recall_numbers": [ "Z-1575-2026", "Z-1576-2026", "Z-1577-2026", "Z-1578-2026", "Z-1579-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218828" }, { "event_id": "98237", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2025-12-19", "classified": "2026-02-05", "reported": "2026-02-11", "product": "HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;", "products": 6, "reason": "Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.", "recall_numbers": [ "Z-1158-2026", "Z-1159-2026", "Z-1160-2026", "Z-1161-2026", "Z-1162-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217955" }, { "event_id": "98049", "slug": "abbott", "firm": "Abbott Diabetes Care, Inc.", "class": "Class I", "initiated": "2025-11-24", "classified": "2026-01-13", "reported": "2026-01-21", "product": "FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.", "products": 4, "reason": "Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results", "recall_numbers": [ "Z-1020-2026", "Z-1021-2026", "Z-1022-2026", "Z-1023-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217499" }, { "event_id": "97703", "slug": "stryker", "firm": "TMJ Solutions Inc", "class": "Class I", "initiated": "2025-10-13", "classified": "2025-11-14", "reported": "2025-11-26", "product": "TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only", "products": 1, "reason": "Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.", "recall_numbers": [ "Z-0488-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216370" }, { "event_id": "97595", "slug": "abbott", "firm": "Abbott", "class": "Class I", "initiated": "2025-09-10", "classified": "2025-10-10", "reported": "2025-10-22", "product": "TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter", "products": 5, "reason": "Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.", "recall_numbers": [ "Z-0109-2026", "Z-0110-2026", "Z-0111-2026", "Z-0112-2026", "Z-0113-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216034" }, { "event_id": "97467", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2025-08-20", "classified": "2025-10-10", "reported": "2025-10-22", "product": "Model Number L211 PROPONENT DR SL MRI Pacemaker", "products": 27, "reason": "Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).", "recall_numbers": [ "Z-0079-2026", "Z-0080-2026", "Z-0081-2026", "Z-0082-2026", "Z-0083-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215651" }, { "event_id": "97295", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class I", "initiated": "2025-08-06", "classified": "2025-09-03", "reported": "2025-09-10", "product": "DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110", "products": 3, "reason": "The catheters may not retain their shape.", "recall_numbers": [ "Z-2480-2025", "Z-2481-2025", "Z-2482-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215107" }, { "event_id": "97363", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2025-07-29", "classified": "2025-08-29", "reported": "2025-09-10", "product": "WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.", "products": 11, "reason": "Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.", "recall_numbers": [ "Z-2426-2025", "Z-2427-2025", "Z-2428-2025", "Z-2429-2025", "Z-2430-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215342" }, { "event_id": "97318", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2025-07-24", "classified": "2025-08-20", "reported": "2025-08-27", "product": "ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296", "products": 3, "reason": "Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.", "recall_numbers": [ "Z-2325-2025", "Z-2326-2025", "Z-2327-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215218" }, { "event_id": "97243", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2025-07-07", "classified": "2025-08-08", "reported": "2025-08-20", "product": "Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL 6.0-22; H749391508210 CAROTID WALLSTENT MONORAIL 8.0-21; H749391508290 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647010 CAROTID WALLSTENT MONORAIL 6.0-22; H965SCH647070 CAROTID WALLSTENT MONORAIL 8.0-21; H965SCH647080 CAROTID WALLSTENT MONORAIL 8.0-29; H965SCH647090 CAROTID WALLSTENT MONORAIL 8.0-36; H965SCH647120 CAROTID WALLSTENT MONORAIL 10.0-24; H965SCH647130 CAROTID WALLSTENT MONORAIL 10.0-31; H965SCH647140 CAROTID WALLSTENT MONORAIL 10.0-37; M001719000 CAROTID WALLSTENT MR 6X22 5F 135CM; M001719010 CAROTID WALLSTENT MR 8X21 5F 135CM; M001719020 CAROTID WALLSTENT MR 8X29 5F 135CM; M001719030 CAROTID WALLSTENT MR 8X36 5F 135CM; M001719040 CAROTID WALLSTENT MR 10X24 5.9F 135CM; M001719050 CAROTID WALLSTENT MR 10X31 5.9F 135CM; M001719060 CAROTID WALLSTENT MR 10X37 5.9F 135CM;", "products": 1, "reason": "Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.", "recall_numbers": [ "Z-2273-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214951" }, { "event_id": "97256", "slug": "abbott", "firm": "Thoratec LLC", "class": "Class I", "initiated": "2025-06-23", "classified": "2025-08-13", "reported": "2025-08-20", "product": "Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3\" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. The HeartMate II Left Ventricular Assist System is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries. The LVAS may be used in any of two configurations. First, line power may be utilized through the Power Module or the Mobile Power Unit (MPU) to run the LVAD indefinitely, convenient for sedentary or sleeping periods. Second, portable Battery power may be utilized for limited periods, convenient for active periods. The MPU AC power cord is distributed either as part of the complete MPU device package or as a standalone accessory. (Labeling - Attachments E1 to E6) Component: Yes, the AC Power Cord is a component of the Mobile Power Unit", "products": 2, "reason": "Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.", "recall_numbers": [ "Z-2290-2025", "Z-2291-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214976" }, { "event_id": "97029", "slug": "medtronic", "firm": "Given Imaging Ltd.", "class": "Class I", "initiated": "2025-06-03", "classified": "2025-07-10", "reported": "2025-07-16", "product": "Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)", "products": 1, "reason": "It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.", "recall_numbers": [ "Z-2047-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214251" }, { "event_id": "96774", "slug": "medtronic", "firm": "Covidien", "class": "Class I", "initiated": "2025-05-21", "classified": "2025-06-09", "reported": "2025-06-18", "product": "Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WW-NA. HT70-2 CONTROL BOARD ROHS, REF: GR-PCB3252A. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.", "products": 1, "reason": "Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.", "recall_numbers": [ "Z-1915-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213582" }, { "event_id": "96943", "slug": "edwards-lifesciences", "firm": "Edwards Lifesciences, LLC", "class": "Class I", "initiated": "2025-05-14", "classified": "2025-07-10", "reported": "2025-07-16", "product": "Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.", "products": 6, "reason": "due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.", "recall_numbers": [ "Z-2080-2025", "Z-2081-2025", "Z-2082-2025", "Z-2083-2025", "Z-2084-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214070" }, { "event_id": "96471", "slug": "abbott", "firm": "Thoratec LLC", "class": "Class I", "initiated": "2025-03-13", "classified": "2025-04-17", "reported": "2025-04-23", "product": "HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.", "products": 1, "reason": "Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.", "recall_numbers": [ "Z-1570-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212942" }, { "event_id": "96371", "slug": "medtronic", "firm": "Covidien", "class": "Class I", "initiated": "2025-02-26", "classified": "2025-03-25", "reported": "2025-04-02", "product": "Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R", "products": 1, "reason": "Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.", "recall_numbers": [ "Z-1390-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212660" }, { "event_id": "96259", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class I", "initiated": "2025-02-05", "classified": "2025-03-13", "reported": "2025-03-19", "product": "Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014", "products": 1, "reason": "Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).", "recall_numbers": [ "Z-1306-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212469" }, { "event_id": "96168", "slug": "medtronic", "firm": "Micro Therapeutics, Inc.", "class": "Class I", "initiated": "2025-01-30", "classified": "2025-03-05", "reported": "2025-03-12", "product": "Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2", "products": 2, "reason": "Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age", "recall_numbers": [ "Z-1245-2025", "Z-1246-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212204" }, { "event_id": "95969", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2024-12-12", "classified": "2025-01-10", "reported": "2025-01-22", "product": "PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).", "products": 6, "reason": "A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.", "recall_numbers": [ "Z-0822-2025", "Z-0823-2025", "Z-0824-2025", "Z-0825-2025", "Z-0826-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211663" }, { "event_id": "95725", "slug": "medtronic", "firm": "Medtronic Neurosurgery", "class": "Class I", "initiated": "2024-11-01", "classified": "2024-12-19", "reported": "2024-12-25", "product": "Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).", "products": 2, "reason": "Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).", "recall_numbers": [ "Z-0661-2025", "Z-0662-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211016" }, { "event_id": "95514", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2024-10-10", "classified": "2024-11-12", "reported": "2024-11-20", "product": "Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100", "products": 7, "reason": "Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.", "recall_numbers": [ "Z-0297-2025", "Z-0298-2025", "Z-0299-2025", "Z-0300-2025", "Z-0301-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210462" }, { "event_id": "95121", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class I", "initiated": "2024-07-31", "classified": "2024-10-03", "reported": "2024-10-09", "product": "MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809, MMT-1810, MMT-1817, MMT-1818, MMT-1859, MMT-1860, MMT-1867, MMT-1868 MiniMed 740G Insulin Pump, REF: MMT-1811, MMT-1812, MMT-1861, MMT-1862", "products": 3, "reason": "Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.", "recall_numbers": [ "Z-0001-2025", "Z-0002-2025", "Z-0003-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209491" }, { "event_id": "95047", "slug": "abbott", "firm": "Abbott Diabetes Care, Inc.", "class": "Class I", "initiated": "2024-07-24", "classified": "2024-08-27", "reported": "2024-09-04", "product": "FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System", "products": 1, "reason": "Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.", "recall_numbers": [ "Z-2692-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209214" }, { "event_id": "95033", "slug": "medtronic", "firm": "Covidien", "class": "Class I", "initiated": "2024-07-09", "classified": "2024-08-21", "reported": "2024-08-28", "product": "McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only", "products": 2, "reason": "Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.", "recall_numbers": [ "Z-2636-2024", "Z-2637-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209173" }, { "event_id": "94855", "slug": "medtronic", "firm": "Covidien", "class": "Class I", "initiated": "2024-06-24", "classified": "2024-08-02", "reported": "2024-08-14", "product": "Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilator LATAM/4096600-04, Puritan Bennett 560 Ventilator EMEA/4096600-05, Puritan Bennett 560 Ventilator CAN ANZ/4096600-06, Puritan Bennett 540 Ventilator USA/4097100 Puritan Bennett 520 Ventilator/4098300, Puritan Bennett 520 Ventilator EU-DIV/4098300-01, Puritan Bennett 520 Ventilator Japan/4098300-02, Puritan Bennett 520 Ventilator APAC/4098300-03, Puritan Bennett 520 Ventilator EMEA/4098300-05, Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06, DL4096600 DL PB560 VENTILATOR/DL4096600, DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06, REFURBISHED PB540 VENTILATOR/DL4097100, Puritan Bennett 540 Ventilator Refurbished/DS4097100", "products": 1, "reason": "Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway", "recall_numbers": [ "Z-2446-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208495" }, { "event_id": "94876", "slug": "medtronic", "firm": "Medtronic Xomed, Inc.", "class": "Class I", "initiated": "2024-06-24", "classified": "2024-07-24", "reported": "2024-07-31", "product": "NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143", "products": 1, "reason": "Potential for false negative response on the NIM Vital Nerve Monitoring System", "recall_numbers": [ "Z-2409-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208537" }, { "event_id": "94478", "slug": "abbott", "firm": "Thoratec Corp.", "class": "Class I", "initiated": "2024-05-08", "classified": "2024-06-07", "reported": "2024-06-19", "product": "Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device", "products": 1, "reason": "System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected", "recall_numbers": [ "Z-1921-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207286" }, { "event_id": "94411", "slug": "medtronic", "firm": "Medtronic Navigation, Inc.", "class": "Class I", "initiated": "2024-03-26", "classified": "2024-05-09", "reported": "2024-05-15", "product": "Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.", "products": 1, "reason": "Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the \"distance to target\" or \"tip stop point\" display during navigation.", "recall_numbers": [ "Z-1776-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207180" }, { "event_id": "94302", "slug": "medtronic", "firm": "SonarMed Inc", "class": "Class I", "initiated": "2024-03-25", "classified": "2024-04-18", "reported": "2024-04-24", "product": "AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.", "products": 1, "reason": "Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.", "recall_numbers": [ "Z-1535-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206885" }, { "event_id": "94240", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2024-03-21", "classified": "2024-05-10", "reported": "2024-05-22", "product": "Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter", "products": 48, "reason": "An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.", "recall_numbers": [ "Z-1638-2024", "Z-1639-2024", "Z-1640-2024", "Z-1641-2024", "Z-1642-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206624" }, { "event_id": "94292", "slug": "medtronic", "firm": "SonarMed Inc", "class": "Class I", "initiated": "2024-03-21", "classified": "2024-04-18", "reported": "2024-04-24", "product": "AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.", "products": 3, "reason": "The failure to detect the partial obstruction in a 2.5mm sensor.", "recall_numbers": [ "Z-1519-2024", "Z-1520-2024", "Z-1521-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206850" }, { "event_id": "94264", "slug": "biomerieux", "firm": "Biomerieux Inc", "class": "Class I", "initiated": "2024-03-14", "classified": "2024-04-25", "reported": "2024-05-01", "product": "VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j) AST-N404, REF 423664; k) AST-N802, REF 423706; l) AST-N405, REF 423864; m) AST-N417, REF 423880; n) AST-N408, REF 423924; o) AST-N409, REF 423925; p) AST-N420, REF 424039; q) AST-N423, REF 424042; r) AST-N422, REF 424056; s) AST-N436, REF 424440; t) AST-N809, REF 424703; u) AST-N806, REF 424709; v) AST-N807, REF 424710; w) AST-N808, REF 424711; x) AST-N810, REF 424712; y) AST-N812, REF 424721", "products": 1, "reason": "Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.", "recall_numbers": [ "Z-1464-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206759" }, { "event_id": "94232", "slug": "abbott", "firm": "Thoratec Corp.", "class": "Class I", "initiated": "2024-03-01", "classified": "2024-05-01", "reported": "2024-05-08", "product": "Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly", "products": 2, "reason": "Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.", "recall_numbers": [ "Z-1692-2024", "Z-1693-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206613" }, { "event_id": "94126", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2024-02-20", "classified": "2024-03-27", "reported": "2024-04-03", "product": "Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010", "products": 1, "reason": "An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.", "recall_numbers": [ "Z-1374-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206388" }, { "event_id": "93963", "slug": "abbott", "firm": "Thoratec Corp.", "class": "Class I", "initiated": "2024-02-19", "classified": "2024-03-21", "reported": "2024-03-27", "product": "HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.", "products": 2, "reason": "Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.", "recall_numbers": [ "Z-1300-2024", "Z-1301-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206012" }, { "event_id": "94082", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class I", "initiated": "2024-02-12", "classified": "2024-03-26", "reported": "2024-04-03", "product": "Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050", "products": 1, "reason": "Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).", "recall_numbers": [ "Z-1302-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206263" }, { "event_id": "93919", "slug": "medtronic", "firm": "Medtronic Neurosurgery", "class": "Class I", "initiated": "2024-01-22", "classified": "2024-02-27", "reported": "2024-03-06", "product": "Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.", "products": 5, "reason": "Potential for catheter disconnection from the patient line stopcock connectors.", "recall_numbers": [ "Z-1162-2024", "Z-1163-2024", "Z-1164-2024", "Z-1165-2024", "Z-1166-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205899" }, { "event_id": "93697", "slug": "abbott", "firm": "Thoratec Corp.", "class": "Class I", "initiated": "2024-01-03", "classified": "2024-02-02", "reported": "2024-02-14", "product": "1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.", "products": 1, "reason": "Due to software and controller systems that results in unexpected pump start or pump stop.", "recall_numbers": [ "Z-0842-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205152" }, { "event_id": "99883", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2026-09-16", "classified": "2026-10-15", "reported": "2026-10-21", "product": "TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.", "products": 4, "reason": "Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.", "recall_numbers": [ "Z-0164-2027", "Z-0165-2027", "Z-0166-2027", "Z-0167-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222800" }, { "event_id": "99829", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-09-10", "classified": "2026-10-09", "reported": "2026-10-21", "product": "NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;", "products": 1, "reason": "Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.", "recall_numbers": [ "Z-0143-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222577" }, { "event_id": "99844", "slug": "abbott", "firm": "Abbott", "class": "Class II", "initiated": "2026-09-10", "classified": "2026-10-16", "reported": "2026-10-28", "product": "Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6. 9-ACP2-010-028 7. 9-ACP2-010-031 8. 9-ACP2-010-034", "products": 1, "reason": "Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).", "recall_numbers": [ "Z-0191-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222724" }, { "event_id": "99949", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2026-09-08", "classified": "2026-10-22", "reported": "2026-10-28", "product": "InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030", "products": 2, "reason": "Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.", "recall_numbers": [ "Z-0266-2027", "Z-0267-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222961" }, { "event_id": "99895", "slug": "medtronic", "firm": "Medtronic Navigation, Inc.", "class": "Class II", "initiated": "2026-08-31", "classified": "2026-10-16", "reported": "2026-10-28", "product": "Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly", "products": 4, "reason": "Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.", "recall_numbers": [ "Z-0194-2027", "Z-0195-2027", "Z-0196-2027", "Z-0197-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222839" }, { "event_id": "99901", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2026-08-27", "classified": "2026-10-15", "reported": "2026-10-21", "product": "Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO", "products": 1, "reason": "The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.", "recall_numbers": [ "Z-0187-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222845" }, { "event_id": "99409", "slug": "abbott", "firm": "Alere San Diego, Inc.", "class": "Class II", "initiated": "2026-08-20", "classified": "2026-09-25", "reported": "2026-10-07", "product": "Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075; Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225; Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021", "products": 4, "reason": "hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.", "recall_numbers": [ "Z-3271-2026", "Z-3272-2026", "Z-3273-2026", "Z-3274-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221510" }, { "event_id": "99634", "slug": "stryker", "firm": "Stryker Sustainability Solutions", "class": "Class II", "initiated": "2026-08-19", "classified": "2026-09-16", "reported": "2026-09-23", "product": "REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM", "products": 6, "reason": "Reusable access port system may crack or seperate during use.", "recall_numbers": [ "Z-3182-2026", "Z-3183-2026", "Z-3184-2026", "Z-3185-2026", "Z-3186-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222032" }, { "event_id": "99651", "slug": "stryker", "firm": "Wright Medical Technology, Inc.", "class": "Class II", "initiated": "2026-08-18", "classified": "2026-09-30", "reported": "2026-10-07", "product": "CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System", "products": 1, "reason": "Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.", "recall_numbers": [ "Z-3334-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222085" }, { "event_id": "99655", "slug": "stryker", "firm": "Stryker Sustainability Solutions", "class": "Class II", "initiated": "2026-08-18", "classified": "2026-10-05", "reported": "2026-10-14", "product": "BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007", "products": 1, "reason": "Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.", "recall_numbers": [ "Z-0085-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222092" }, { "event_id": "99592", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2026-08-12", "classified": "2026-10-13", "reported": "2026-10-21", "product": "Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135 (6 Kit) Software Version: N/A Product Description: Mulitple-type osteoarticular pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A", "products": 3, "reason": "Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results", "recall_numbers": [ "Z-0148-2027", "Z-0149-2027", "Z-0150-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221921" }, { "event_id": "99701", "slug": "medtronic", "firm": "Medtronic Sofamor Danek USA Inc", "class": "Class II", "initiated": "2026-08-12", "classified": "2026-10-09", "reported": "2026-10-21", "product": "Grafton\" DBM and Grafton Plus\" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft product having a particular physical form and/or handling property. Grafton DBM Gel and Grafton Plus DBM Paste are produced from a powder form of DBM, while Grafton DBM Flex, Putty, Matrix, Crunch\" and Orthoblend are produced from a fiber form of DBM Crunch\" also contains demineralized bone chips/cubes, while Grafton DBM Orthoblend contains non-demineralized cancellous bone chips in addition to DBM. Grafton DBM and Grafton Plus DBM are malleable and can be molded or cut into various sizes and shapes according to the intended implant site.", "products": 2, "reason": "Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and while tissue did undergo gamma radiation, if implanted, there is a possibility of clostridium infection.", "recall_numbers": [ "Z-0137-2027", "Z-0138-2027" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222236" }, { "event_id": "99541", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2026-08-10", "classified": "2026-09-25", "reported": "2026-10-07", "product": "Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA", "products": 1, "reason": "Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.", "recall_numbers": [ "Z-3305-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221797" }, { "event_id": "99524", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-08-06", "classified": "2026-09-02", "reported": "2026-09-09", "product": "LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)", "products": 3, "reason": "There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.", "recall_numbers": [ "Z-3081-2026", "Z-3082-2026", "Z-3083-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221738" }, { "event_id": "99558", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2026-07-30", "classified": "2026-09-16", "reported": "2026-09-23", "product": "SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)", "products": 12, "reason": "Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.", "recall_numbers": [ "Z-3195-2026", "Z-3196-2026", "Z-3197-2026", "Z-3198-2026", "Z-3199-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221858" }, { "event_id": "99568", "slug": "stryker", "firm": "HeartSine Technologies Ltd", "class": "Class II", "initiated": "2026-07-27", "classified": "2026-09-04", "reported": "2026-09-16", "product": "HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069 The HeartSine samaritan¿ PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: \" Unconscious \" Not breathing \" Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).", "products": 1, "reason": "Due to a damaged (over stretched) membrane tail that causes an intermittent fault.", "recall_numbers": [ "Z-3120-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221890" }, { "event_id": "99749", "slug": "biomerieux", "firm": "Biomerieux Inc", "class": "Class II", "initiated": "2026-07-24", "classified": "2026-09-18", "reported": "2026-09-30", "product": "VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811", "products": 1, "reason": "The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.", "recall_numbers": [ "Z-3231-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222401" }, { "event_id": "99630", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-07-22", "classified": "2026-09-16", "reported": "2026-09-23", "product": "Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0", "products": 1, "reason": "A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.", "recall_numbers": [ "Z-3188-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222047" }, { "event_id": "99459", "slug": "biomerieux", "firm": "Biofire Defense", "class": "Class II", "initiated": "2026-07-16", "classified": "2026-08-04", "reported": "2026-08-12", "product": "FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).", "products": 1, "reason": "Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.", "recall_numbers": [ "Z-2877-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221599" }, { "event_id": "99435", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-07-14", "classified": "2026-08-14", "reported": "2026-08-26", "product": "OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.", "products": 2, "reason": "Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.", "recall_numbers": [ "Z-2961-2026", "Z-2962-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221549" }, { "event_id": "99246", "slug": "stryker", "firm": "Stryker GmbH", "class": "Class II", "initiated": "2026-07-01", "classified": "2026-07-29", "reported": "2026-08-05", "product": "Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.", "products": 7, "reason": "Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.", "recall_numbers": [ "Z-2827-2026", "Z-2828-2026", "Z-2829-2026", "Z-2830-2026", "Z-2831-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221135" }, { "event_id": "99300", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-06-30", "classified": "2026-07-31", "reported": "2026-08-12", "product": "Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.", "products": 3, "reason": "Potential for breach in sterile barrier of device packaging.", "recall_numbers": [ "Z-2838-2026", "Z-2839-2026", "Z-2840-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221234" }, { "event_id": "99336", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-06-30", "classified": "2026-07-10", "reported": "2026-07-22", "product": "Rapid Refill Continuous Injection System, UPN M00566001", "products": 1, "reason": "Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.", "recall_numbers": [ "Z-2725-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221336" }, { "event_id": "99689", "slug": "medtronic", "firm": "Micro Therapeutics, Inc.", "class": "Class II", "initiated": "2026-06-25", "classified": "2026-09-28", "reported": "2026-10-07", "product": "Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization Device with Shield Technology implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires and indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.", "products": 1, "reason": "Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter.", "recall_numbers": [ "Z-3326-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222202" }, { "event_id": "99261", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2026-06-24", "classified": "2026-08-12", "reported": "2026-08-19", "product": "BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic", "products": 1, "reason": "Due to increase in false negative results", "recall_numbers": [ "Z-2936-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221164" }, { "event_id": "99320", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2026-06-24", "classified": "2026-07-27", "reported": "2026-08-05", "product": "EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722", "products": 6, "reason": "Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.", "recall_numbers": [ "Z-2806-2026", "Z-2807-2026", "Z-2808-2026", "Z-2809-2026", "Z-2810-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221276" }, { "event_id": "99390", "slug": "medtronic", "firm": "Covidien, LP", "class": "Class II", "initiated": "2026-06-24", "classified": "2026-08-07", "reported": "2026-08-19", "product": "V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246", "products": 5, "reason": "Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.", "recall_numbers": [ "Z-2918-2026", "Z-2919-2026", "Z-2920-2026", "Z-2921-2026", "Z-2922-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221459" }, { "event_id": "99236", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-06-19", "classified": "2026-07-22", "reported": "2026-07-29", "product": "Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.", "products": 1, "reason": "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects \"Recalculate\", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.", "recall_numbers": [ "Z-2771-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221119" }, { "event_id": "99342", "slug": "medtronic", "firm": "Medtronic Neurosurgery", "class": "Class II", "initiated": "2026-06-17", "classified": "2026-07-21", "reported": "2026-07-29", "product": "Ventriculostomy Kit, REF: 46154", "products": 1, "reason": "Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.", "recall_numbers": [ "Z-2768-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221365" }, { "event_id": "99230", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-06-11", "classified": "2026-07-17", "reported": "2026-07-29", "product": "FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter", "products": 3, "reason": "Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.", "recall_numbers": [ "Z-2750-2026", "Z-2751-2026", "Z-2752-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221107" }, { "event_id": "99251", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-06-11", "classified": "2026-07-17", "reported": "2026-07-29", "product": "FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter", "products": 1, "reason": "Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.", "recall_numbers": [ "Z-2753-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221149" }, { "event_id": "99252", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-06-11", "classified": "2026-07-17", "reported": "2026-07-29", "product": "FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062", "products": 4, "reason": "Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.", "recall_numbers": [ "Z-2754-2026", "Z-2755-2026", "Z-2756-2026", "Z-2757-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221150" }, { "event_id": "99268", "slug": "roche", "firm": "Foundation Medicine, Inc.", "class": "Class II", "initiated": "2026-06-10", "classified": "2026-08-14", "reported": "2026-08-26", "product": "Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.", "products": 1, "reason": "Software issue that can cause an increase in spontaneous software closures.", "recall_numbers": [ "Z-2951-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221172" }, { "event_id": "99326", "slug": "medtronic", "firm": "Micro Therapeutics, Inc.", "class": "Class II", "initiated": "2026-06-08", "classified": "2026-07-22", "reported": "2026-07-29", "product": "Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter", "products": 2, "reason": "Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.", "recall_numbers": [ "Z-2773-2026", "Z-2774-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221301" }, { "event_id": "99340", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2026-06-08", "classified": "2026-08-03", "reported": "2026-08-12", "product": "STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640", "products": 5, "reason": "There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.", "recall_numbers": [ "Z-2862-2026", "Z-2863-2026", "Z-2864-2026", "Z-2865-2026", "Z-2866-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221356" }, { "event_id": "99213", "slug": "biomerieux", "firm": "Biomerieux Inc", "class": "Class II", "initiated": "2026-06-04", "classified": "2026-07-09", "reported": "2026-07-15", "product": "VITEK 2 AST-N447 TEST KIT Product reference 424620", "products": 1, "reason": "Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.", "recall_numbers": [ "Z-2715-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221078" }, { "event_id": "99199", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2026-05-25", "classified": "2026-07-15", "reported": "2026-07-22", "product": "Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula", "products": 2, "reason": "Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.", "recall_numbers": [ "Z-2738-2026", "Z-2739-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=221037" }, { "event_id": "99067", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-05-21", "classified": "2026-07-01", "reported": "2026-07-08", "product": "CRE Pro Wireguided 12-15mm 240cm", "products": 12, "reason": "Potential sterile breach of the pouches in which devices are packaged.", "recall_numbers": [ "Z-2626-2026", "Z-2627-2026", "Z-2628-2026", "Z-2629-2026", "Z-2630-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220730" }, { "event_id": "99041", "slug": "medtronic", "firm": "Medtronic Navigation, Inc.-Boxborough", "class": "Class II", "initiated": "2026-05-19", "classified": "2026-06-15", "reported": "2026-06-24", "product": "Medtronic O-arm O2 Imaging System. Model Number: BI70002000.", "products": 1, "reason": "Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.", "recall_numbers": [ "Z-2451-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220683" }, { "event_id": "99080", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2026-05-19", "classified": "2026-06-17", "reported": "2026-06-24", "product": "TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.", "products": 2, "reason": "Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).", "recall_numbers": [ "Z-2461-2026", "Z-2462-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220758" }, { "event_id": "98913", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2026-05-13", "classified": "2026-05-28", "reported": "2026-06-03", "product": "Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor", "products": 2, "reason": "A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.", "recall_numbers": [ "Z-2240-2026", "Z-2241-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220167" }, { "event_id": "99023", "slug": "abbott", "firm": "Thoratec LLC", "class": "Class II", "initiated": "2026-05-13", "classified": "2026-06-18", "reported": "2026-06-24", "product": "Brand Name: HeartMate Product Name: HeartMate 3\" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3\" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch\" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 Left Ventricular System (LVAS) Kits", "products": 3, "reason": "Due to 11 volt Backup Battery failures.", "recall_numbers": [ "Z-2518-2026", "Z-2519-2026", "Z-2520-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220518" }, { "event_id": "99176", "slug": "medtronic", "firm": "Covidien, LLC", "class": "Class II", "initiated": "2026-05-13", "classified": "2026-08-14", "reported": "2026-08-26", "product": "EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.", "products": 1, "reason": "The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.", "recall_numbers": [ "Z-2950-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220982" }, { "event_id": "98963", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2026-05-12", "classified": "2026-06-11", "reported": "2026-06-17", "product": "Merlin\" Patient Care System (PCS) software Merlin\" PCS 3650 programmer Model 3330 software", "products": 1, "reason": "Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.", "recall_numbers": [ "Z-2405-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220288" }, { "event_id": "98966", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2026-05-12", "classified": "2026-06-24", "reported": "2026-07-01", "product": "Octopus Evolution AS Tissue Stabilizer, Model TS2500", "products": 3, "reason": "During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.", "recall_numbers": [ "Z-2575-2026", "Z-2576-2026", "Z-2577-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220291" }, { "event_id": "98970", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-05-12", "classified": "2026-06-11", "reported": "2026-06-17", "product": "Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.", "products": 1, "reason": "Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.", "recall_numbers": [ "Z-2413-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220308" }, { "event_id": "99063", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-05-11", "classified": "2026-06-25", "reported": "2026-07-01", "product": "Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device", "products": 1, "reason": "There is the potential for leakage along the drug pathway from the pump through the end of the catheter.", "recall_numbers": [ "Z-2580-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220721" }, { "event_id": "98818", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2026-05-08", "classified": "2026-06-18", "reported": "2026-06-24", "product": "Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.", "products": 1, "reason": "Due to unsealed portions of pouches.", "recall_numbers": [ "Z-2517-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219884" }, { "event_id": "98894", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2026-05-06", "classified": "2026-06-01", "reported": "2026-06-10", "product": "Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System", "products": 1, "reason": "It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.", "recall_numbers": [ "Z-2282-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220096" }, { "event_id": "98939", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class II", "initiated": "2026-04-29", "classified": "2026-06-11", "reported": "2026-06-17", "product": "Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm) REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm); REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm)", "products": 2, "reason": "Reusable electrodes may not meet expected performance levels.", "recall_numbers": [ "Z-2402-2026", "Z-2403-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220248" }, { "event_id": "98941", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class II", "initiated": "2026-04-29", "classified": "2026-06-11", "reported": "2026-06-17", "product": "Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180", "products": 1, "reason": "Sterile anchors my lack sterility assurance.", "recall_numbers": [ "Z-2404-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220250" }, { "event_id": "98819", "slug": "medtronic", "firm": "Covidien LLC", "class": "Class II", "initiated": "2026-04-23", "classified": "2026-07-02", "reported": "2026-07-08", "product": "Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.", "products": 1, "reason": "Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.", "recall_numbers": [ "Z-2653-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219885" }, { "event_id": "98859", "slug": "medtronic", "firm": "Covidien LLC", "class": "Class II", "initiated": "2026-04-23", "classified": "2026-05-29", "reported": "2026-06-10", "product": "Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050", "products": 3, "reason": "Temperature probe devices lack FDA clearance.", "recall_numbers": [ "Z-2271-2026", "Z-2272-2026", "Z-2273-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220016" }, { "event_id": "98776", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2026-04-22", "classified": "2026-05-06", "reported": "2026-05-13", "product": "BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.", "products": 1, "reason": "Contamination to in-vitro diagnostic test may result in false positives.", "recall_numbers": [ "Z-2067-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219761" }, { "event_id": "98933", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class II", "initiated": "2026-04-22", "classified": "2026-07-08", "reported": "2026-07-15", "product": "Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU", "products": 1, "reason": "Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.", "recall_numbers": [ "Z-2694-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220233" }, { "event_id": "98786", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2026-04-21", "classified": "2026-05-20", "reported": "2026-05-27", "product": "Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter", "products": 9, "reason": "Certain lots of product have the potential for a sterile barrier breach.", "recall_numbers": [ "Z-2214-2026", "Z-2215-2026", "Z-2216-2026", "Z-2217-2026", "Z-2218-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219824" }, { "event_id": "98998", "slug": "roche", "firm": "Ventana Medical Systems, Inc.", "class": "Class II", "initiated": "2026-04-20", "classified": "2026-08-07", "reported": "2026-08-19", "product": "navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Pathology software (previously known as uPath Enterprise Software) is a component of the Roche Digital Pathology Dx device cleared by the US FDA for Whole Slide Imaging purposes. Roche Digital Pathology Dx is an automated digital slide creation, viewing, and management system.", "products": 1, "reason": "Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window", "recall_numbers": [ "Z-2913-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220432" }, { "event_id": "98813", "slug": "medtronic", "firm": "Covidien LLC", "class": "Class II", "initiated": "2026-04-15", "classified": "2026-05-29", "reported": "2026-06-10", "product": "COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.", "products": 1, "reason": "Due to customer complaint regarding incorrect display box labeling.", "recall_numbers": [ "Z-2261-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219873" }, { "event_id": "98871", "slug": "medtronic", "firm": "Covidien, LP", "class": "Class II", "initiated": "2026-04-15", "classified": "2026-06-01", "reported": "2026-06-10", "product": "Covidien EndoStitch\" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;", "products": 1, "reason": "The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.", "recall_numbers": [ "Z-2281-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220053" }, { "event_id": "98417", "slug": "stryker", "firm": "Jolife AB", "class": "Class II", "initiated": "2026-04-13", "classified": "2026-05-11", "reported": "2026-05-20", "product": "LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 00883873834329 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.", "products": 1, "reason": "Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).", "recall_numbers": [ "Z-2161-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218655" }, { "event_id": "98418", "slug": "stryker", "firm": "Physio-Control, Inc.", "class": "Class II", "initiated": "2026-04-13", "classified": "2026-05-04", "reported": "2026-05-13", "product": "LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122", "products": 1, "reason": "Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.", "recall_numbers": [ "Z-2065-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218656" }, { "event_id": "98708", "slug": "stryker", "firm": "Stryker Sustainability Solutions", "class": "Class II", "initiated": "2026-04-10", "classified": "2026-05-13", "reported": "2026-05-20", "product": "BARD Dynamic Tip Steerable, Product Number 6DYNTP001;", "products": 26, "reason": "Incomplete seals on sterile product", "recall_numbers": [ "Z-2174-2026", "Z-2175-2026", "Z-2176-2026", "Z-2177-2026", "Z-2178-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219549" }, { "event_id": "98696", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2026-04-09", "classified": "2026-05-12", "reported": "2026-05-20", "product": "Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.", "products": 1, "reason": "Due to nonconforming products being inadvertently distributed.", "recall_numbers": [ "Z-2166-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219497" }, { "event_id": "98750", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2026-04-08", "classified": "2026-05-14", "reported": "2026-05-20", "product": "Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump", "products": 1, "reason": "Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.", "recall_numbers": [ "Z-2201-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219693" }, { "event_id": "98630", "slug": "stryker", "firm": "Stryker Neurovascular", "class": "Class II", "initiated": "2026-04-06", "classified": "2026-06-24", "reported": "2026-07-01", "product": "INZONE DETACHMENT SYSTEM, REF: M00345100950", "products": 1, "reason": "Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.", "recall_numbers": [ "Z-2552-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219266" }, { "event_id": "98637", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2026-04-02", "classified": "2026-04-29", "reported": "2026-05-06", "product": "Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY", "products": 3, "reason": "catheter may experience resistance when being advanced over the guidewire", "recall_numbers": [ "Z-2002-2026", "Z-2003-2026", "Z-2004-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219322" }, { "event_id": "98635", "slug": "abbott", "firm": "Abbott Point Of Care Inc.", "class": "Class II", "initiated": "2026-04-01", "classified": "2026-04-29", "reported": "2026-05-06", "product": "i-STAT G3+ cartridge; List Number: 03P78-26;", "products": 3, "reason": "Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.", "recall_numbers": [ "Z-1999-2026", "Z-2000-2026", "Z-2001-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219276" }, { "event_id": "98719", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2026-04-01", "classified": "2026-05-06", "reported": "2026-05-13", "product": "Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485", "products": 1, "reason": "Respiratory/sore throat panel test may result in false negative results and control failures.", "recall_numbers": [ "Z-2081-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219560" }, { "event_id": "98679", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-03-30", "classified": "2026-05-01", "reported": "2026-05-13", "product": "LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5", "products": 2, "reason": "For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.", "recall_numbers": [ "Z-2048-2026", "Z-2049-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219421" }, { "event_id": "98633", "slug": "edwards-lifesciences", "firm": "Edwards Lifesciences, LLC", "class": "Class II", "initiated": "2026-03-27", "classified": "2026-05-13", "reported": "2026-05-20", "product": "Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO", "products": 1, "reason": "Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.", "recall_numbers": [ "Z-2172-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219274" }, { "event_id": "98640", "slug": "roche", "firm": "Foundation Medicine, Inc.", "class": "Class II", "initiated": "2026-03-24", "classified": "2026-04-23", "reported": "2026-04-29", "product": "Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.", "products": 1, "reason": "Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.", "recall_numbers": [ "Z-1937-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219291" }, { "event_id": "98625", "slug": "roche", "firm": "Foundation Medicine, Inc.", "class": "Class II", "initiated": "2026-03-20", "classified": "2026-04-22", "reported": "2026-04-29", "product": "Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)", "products": 1, "reason": "Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants", "recall_numbers": [ "Z-1927-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219260" }, { "event_id": "98504", "slug": "stryker", "firm": "Stryker Sustainability Solutions", "class": "Class II", "initiated": "2026-03-12", "classified": "2026-04-09", "reported": "2026-04-15", "product": "Stryker Sustainability Solution Color Cuff 24\" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18\" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18\" (Red) Dual Port Single Bladder REF 5921-018-235.", "products": 1, "reason": "Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.", "recall_numbers": [ "Z-1804-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218944" }, { "event_id": "98653", "slug": "medtronic", "firm": "Medtronic, Inc.", "class": "Class II", "initiated": "2026-03-11", "classified": "2026-04-24", "reported": "2026-05-06", "product": "Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.", "products": 1, "reason": "Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.", "recall_numbers": [ "Z-1948-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219345" }, { "event_id": "98512", "slug": "stryker", "firm": "Tornier, Inc", "class": "Class II", "initiated": "2026-03-05", "classified": "2026-04-03", "reported": "2026-04-15", "product": "Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252", "products": 1, "reason": "Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.", "recall_numbers": [ "Z-1769-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218955" }, { "event_id": "98514", "slug": "stryker", "firm": "Stryker Communications", "class": "Class II", "initiated": "2026-02-23", "classified": "2026-03-27", "reported": "2026-04-08", "product": "Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001", "products": 1, "reason": "Surgical light assembly may not adequate support the weight of the ceiling cover.", "recall_numbers": [ "Z-1688-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218964" }, { "event_id": "98426", "slug": "stryker", "firm": "Stryker Medical Division of Stryker Corporation", "class": "Class II", "initiated": "2026-02-18", "classified": "2026-03-19", "reported": "2026-03-25", "product": "Cub Pediatric Crib, Model FL19H", "products": 1, "reason": "Cribs sold in the USA are missing two access door warning labels.", "recall_numbers": [ "Z-1580-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218684" }, { "event_id": "98186", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2026-02-13", "classified": "2026-04-02", "reported": "2026-04-08", "product": "MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)", "products": 14, "reason": "All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.", "recall_numbers": [ "Z-1739-2026", "Z-1740-2026", "Z-1741-2026", "Z-1742-2026", "Z-1743-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217834" }, { "event_id": "98509", "slug": "stryker", "firm": "TMJ Solutions Inc", "class": "Class II", "initiated": "2026-02-11", "classified": "2026-06-22", "reported": "2026-07-01", "product": "TMJ Bilateral Implants, REF: CHG020", "products": 1, "reason": "Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.", "recall_numbers": [ "Z-2524-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218948" }, { "event_id": "98412", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2026-02-10", "classified": "2026-03-11", "reported": "2026-03-18", "product": "EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;", "products": 1, "reason": "Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit.", "recall_numbers": [ "Z-1551-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218643" }, { "event_id": "98400", "slug": "abbott", "firm": "Abbott Diagnostics Scarborough, Inc.", "class": "Class II", "initiated": "2026-02-09", "classified": "2026-03-13", "reported": "2026-03-25", "product": "Product Name: ID NOW\" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable", "products": 1, "reason": "It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.", "recall_numbers": [ "Z-1565-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218604" }, { "event_id": "98411", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2026-02-02", "classified": "2026-03-18", "reported": "2026-03-25", "product": "MICS3 Angled Sagittal Saw Attachment; Part Number: 210490", "products": 1, "reason": "A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.", "recall_numbers": [ "Z-1572-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218642" }, { "event_id": "98548", "slug": "artivion", "firm": "On-X Life Technologies, Inc.", "class": "Class II", "initiated": "2026-02-01", "classified": "2026-05-08", "reported": "2026-05-20", "product": "On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33", "products": 1, "reason": "Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.", "recall_numbers": [ "Z-2133-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=219053" }, { "event_id": "98407", "slug": "medtronic", "firm": "Covidien LLC", "class": "Class II", "initiated": "2026-01-30", "classified": "2026-03-11", "reported": "2026-03-18", "product": "HealthCast \"Vital Sync\" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync\" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).", "products": 1, "reason": "Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.", "recall_numbers": [ "Z-1557-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218630" }, { "event_id": "98444", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2026-01-30", "classified": "2026-03-24", "reported": "2026-04-01", "product": "MiniMed\" 780G - MMT-1884 MiniMed\" 780G - MMT-1886 With Software 6.60 and 6.61", "products": 1, "reason": "Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).", "recall_numbers": [ "Z-1635-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218770" }, { "event_id": "98365", "slug": "otsuka-holdings", "firm": "ReCor Medical Inc.", "class": "Class II", "initiated": "2026-01-29", "classified": "2026-03-27", "reported": "2026-04-08", "product": "Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation", "products": 2, "reason": "Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.", "recall_numbers": [ "Z-1654-2026", "Z-1655-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218620" }, { "event_id": "98257", "slug": "stryker", "firm": "Physio-Control, Inc.", "class": "Class II", "initiated": "2026-01-21", "classified": "2026-03-10", "reported": "2026-03-18", "product": "PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).", "products": 1, "reason": "Due to pediatric defibrillator electrode delamination", "recall_numbers": [ "Z-1544-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218033" }, { "event_id": "98295", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2026-01-21", "classified": "2026-02-17", "reported": "2026-02-25", "product": "MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.", "products": 1, "reason": "Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.", "recall_numbers": [ "Z-1427-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218198" }, { "event_id": "98347", "slug": "roche", "firm": "Roche Diagnostics Operations, Inc.", "class": "Class II", "initiated": "2026-01-20", "classified": "2026-02-27", "reported": "2026-03-11", "product": "cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL", "products": 1, "reason": "Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.", "recall_numbers": [ "Z-1476-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218375" }, { "event_id": "98354", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2026-01-13", "classified": "2026-02-26", "reported": "2026-03-04", "product": "Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1", "products": 1, "reason": "During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.", "recall_numbers": [ "Z-1473-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218440" }, { "event_id": "98268", "slug": "biomerieux", "firm": "Biomerieux Inc", "class": "Class II", "initiated": "2026-01-05", "classified": "2026-02-02", "reported": "2026-02-11", "product": "VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.*** AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491", "products": 1, "reason": "Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.", "recall_numbers": [ "Z-1236-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218083" }, { "event_id": "98123", "slug": "stryker", "firm": "Tornier, Inc", "class": "Class II", "initiated": "2025-12-19", "classified": "2026-02-02", "reported": "2026-02-11", "product": "TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318", "products": 1, "reason": "A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.", "recall_numbers": [ "Z-1237-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217664" }, { "event_id": "98199", "slug": "medtronic", "firm": "Mazor Robotics Ltd", "class": "Class II", "initiated": "2025-12-10", "classified": "2026-01-16", "reported": "2026-01-28", "product": "Mazor X robotic guidance system REF: TPL0059", "products": 1, "reason": "Software errors that can result in incorrect surgical instrument positioning during spinal surgery.", "recall_numbers": [ "Z-1122-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217882" }, { "event_id": "98218", "slug": "stryker", "firm": "LimFlow, Inc.", "class": "Class II", "initiated": "2025-12-05", "classified": "2026-01-29", "reported": "2026-02-04", "product": "Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23", "products": 1, "reason": "Incorrect expiration date", "recall_numbers": [ "Z-1218-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217912" }, { "event_id": "98099", "slug": "stryker", "firm": "Mobius Imaging, LLC", "class": "Class II", "initiated": "2025-12-04", "classified": "2026-01-09", "reported": "2026-01-21", "product": "Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.", "products": 2, "reason": "AIRO pendant replacement kits and upgrade do not possess the \"Safe Hand Position Warning\" label.", "recall_numbers": [ "Z-1040-2026", "Z-1041-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217619" }, { "event_id": "98139", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2025-12-04", "classified": "2026-01-16", "reported": "2026-01-28", "product": "Allwell Inflation Device, for angiographic use REF: IS-30-A", "products": 7, "reason": "Inflation device handle may detach from the syringe during procedure.", "recall_numbers": [ "Z-1123-2026", "Z-1124-2026", "Z-1125-2026", "Z-1126-2026", "Z-1127-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217699" }, { "event_id": "98157", "slug": "medtronic", "firm": "Medtronic Inc", "class": "Class II", "initiated": "2025-12-04", "classified": "2026-01-15", "reported": "2026-01-21", "product": "Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090", "products": 1, "reason": "Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.", "recall_numbers": [ "Z-1098-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217744" }, { "event_id": "98097", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2025-12-03", "classified": "2026-01-09", "reported": "2026-01-21", "product": "A71200 Vanta\" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).", "products": 1, "reason": "Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.", "recall_numbers": [ "Z-1043-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217610" }, { "event_id": "98149", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2025-12-03", "classified": "2026-01-09", "reported": "2026-01-21", "product": "Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal", "products": 1, "reason": "Boston Scientific is initiating the removal of certain batches of Coyote\" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.", "recall_numbers": [ "Z-1042-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217716" }, { "event_id": "98103", "slug": "roche", "firm": "Roche Diagnostics Operations, Inc.", "class": "Class II", "initiated": "2025-11-21", "classified": "2026-01-02", "reported": "2026-01-14", "product": "The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.", "products": 1, "reason": "Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.", "recall_numbers": [ "Z-1009-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217618" }, { "event_id": "98028", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2025-11-20", "classified": "2025-12-23", "reported": "2025-12-31", "product": "Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG", "products": 1, "reason": "Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.", "recall_numbers": [ "Z-0996-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217454" }, { "event_id": "97904", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2025-11-13", "classified": "2025-12-18", "reported": "2025-12-24", "product": "InPen App, Model/CFN Number: MMT-8061 (Android Users)", "products": 1, "reason": "When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.", "recall_numbers": [ "Z-0958-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217080" }, { "event_id": "98031", "slug": "abbott", "firm": "Abbott Laboratories", "class": "Class II", "initiated": "2025-11-13", "classified": "2025-12-18", "reported": "2025-12-24", "product": "Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20", "products": 1, "reason": "Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.", "recall_numbers": [ "Z-0961-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217458" }, { "event_id": "97988", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2025-11-12", "classified": "2025-12-19", "reported": "2025-12-31", "product": "The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.", "products": 1, "reason": "When the device is activated during surgery, the device software issues an error message \"Instrument Face Mask (6001385000000) is not valid for this application\" resulting in an inability to use the device.", "recall_numbers": [ "Z-0963-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217390" }, { "event_id": "97997", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2025-11-02", "classified": "2026-02-02", "reported": "2026-02-11", "product": "MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.", "products": 1, "reason": "A software timing and processor communication issue in MiniMed\" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.", "recall_numbers": [ "Z-1238-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217402" }, { "event_id": "97833", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2025-10-31", "classified": "2025-11-26", "reported": "2025-12-03", "product": "NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;", "products": 3, "reason": "Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.", "recall_numbers": [ "Z-0599-2026", "Z-0600-2026", "Z-0601-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216697" }, { "event_id": "97953", "slug": "stryker", "firm": "Stryker Medical Division of Stryker Corporation", "class": "Class II", "initiated": "2025-10-31", "classified": "2025-12-11", "reported": "2025-12-17", "product": "Stryker Arise 1000EX mattress, Part Number 2236000000", "products": 2, "reason": "Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.", "recall_numbers": [ "Z-0918-2026", "Z-0919-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217312" }, { "event_id": "97910", "slug": "medtronic", "firm": "Medtronic, Inc.", "class": "Class II", "initiated": "2025-10-29", "classified": "2025-11-28", "reported": "2025-12-10", "product": "Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4", "products": 1, "reason": "There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.", "recall_numbers": [ "Z-0726-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217134" }, { "event_id": "97996", "slug": "medtronic", "firm": "Medicrea International", "class": "Class II", "initiated": "2025-10-29", "classified": "2026-01-09", "reported": "2026-01-21", "product": "Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174", "products": 2, "reason": "Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.", "recall_numbers": [ "Z-1038-2026", "Z-1039-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217403" }, { "event_id": "97870", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2025-10-22", "classified": "2025-11-26", "reported": "2025-12-03", "product": "BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)", "products": 1, "reason": "Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.", "recall_numbers": [ "Z-0602-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216846" }, { "event_id": "97873", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2025-10-21", "classified": "2025-11-25", "reported": "2025-12-03", "product": "CareLink Clinic, REF: MMT-7350", "products": 1, "reason": "Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.", "recall_numbers": [ "Z-0594-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216852" }, { "event_id": "97912", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2025-10-20", "classified": "2025-11-18", "reported": "2025-11-26", "product": "Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03", "products": 1, "reason": "Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.", "recall_numbers": [ "Z-0539-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=217136" }, { "event_id": "97784", "slug": "abbott", "firm": "Thoratec LLC", "class": "Class II", "initiated": "2025-10-10", "classified": "2026-01-15", "reported": "2026-01-21", "product": "CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System", "products": 1, "reason": "Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.", "recall_numbers": [ "Z-1099-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216566" }, { "event_id": "97782", "slug": "abbott", "firm": "Thoratec LLC", "class": "Class II", "initiated": "2025-10-09", "classified": "2025-11-14", "reported": "2025-11-26", "product": "Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3\" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch\" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 LVAS", "products": 4, "reason": "Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.", "recall_numbers": [ "Z-0505-2026", "Z-0506-2026", "Z-0507-2026", "Z-0508-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216560" }, { "event_id": "97754", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2025-10-06", "classified": "2025-11-07", "reported": "2025-11-19", "product": "Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400", "products": 2, "reason": "There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).", "recall_numbers": [ "Z-0458-2026", "Z-0459-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216508" }, { "event_id": "97806", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2025-10-03", "classified": "2025-11-14", "reported": "2025-11-26", "product": "MC3 VitalFlow Console, REF 58100; Blood pump of ecmo", "products": 1, "reason": "As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.", "recall_numbers": [ "Z-0509-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216620" }, { "event_id": "97792", "slug": "medtronic", "firm": "Covidien, LP", "class": "Class II", "initiated": "2025-09-25", "classified": "2025-11-07", "reported": "2025-11-19", "product": "Covidien Signia\" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;", "products": 2, "reason": "A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.", "recall_numbers": [ "Z-0485-2026", "Z-0486-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216580" }, { "event_id": "97694", "slug": "stryker", "firm": "Stryker Sustainability Solutions", "class": "Class II", "initiated": "2025-09-24", "classified": "2025-11-12", "reported": "2025-11-19", "product": "HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY", "products": 1, "reason": "Due to manufacturing issue, reprocessed shears, may become stuck in the \"on position\" resulting in continuous activation.", "recall_numbers": [ "Z-0490-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216355" }, { "event_id": "97651", "slug": "stryker", "firm": "HeartSine Technologies Ltd", "class": "Class II", "initiated": "2025-09-18", "classified": "2025-10-23", "reported": "2025-10-29", "product": "HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J", "products": 1, "reason": "Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.", "recall_numbers": [ "Z-0288-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216250" }, { "event_id": "97788", "slug": "abbott", "firm": "Abbott Laboratories", "class": "Class II", "initiated": "2025-09-18", "classified": "2025-11-12", "reported": "2025-11-19", "product": "Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No", "products": 1, "reason": "Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.", "recall_numbers": [ "Z-0489-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216573" }, { "event_id": "97714", "slug": "medtronic", "firm": "Medtronic Sofamor Danek USA Inc", "class": "Class II", "initiated": "2025-09-16", "classified": "2025-11-21", "reported": "2025-12-03", "product": "Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217.", "products": 1, "reason": "Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.", "recall_numbers": [ "Z-0580-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216383" }, { "event_id": "97702", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2025-09-12", "classified": "2025-11-10", "reported": "2025-11-19", "product": "Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B", "products": 1, "reason": "Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.", "recall_numbers": [ "Z-0487-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216369" }, { "event_id": "97603", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2025-09-11", "classified": "2025-10-10", "reported": "2025-10-22", "product": "TENACIO Pump without InhibiZone; UPN: 72404420;", "products": 7, "reason": "The potential for devices to experience inflation and/or deflation performance issues or difficulties.", "recall_numbers": [ "Z-0138-2026", "Z-0139-2026", "Z-0140-2026", "Z-0141-2026", "Z-0142-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216081" }, { "event_id": "97529", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2025-08-28", "classified": "2025-09-23", "reported": "2025-10-01", "product": "Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);", "products": 1, "reason": "The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.", "recall_numbers": [ "Z-2618-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215852" }, { "event_id": "97559", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2025-08-28", "classified": "2025-09-26", "reported": "2025-10-08", "product": "1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;", "products": 1, "reason": "a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.", "recall_numbers": [ "Z-2640-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215924" }, { "event_id": "97442", "slug": "abbott", "firm": "Abbott Point Of Care Inc.", "class": "Class II", "initiated": "2025-08-21", "classified": "2025-09-17", "reported": "2025-09-24", "product": "i-STAT CG4+ cartridge (white). List Number: 03P85-25.", "products": 1, "reason": "Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.", "recall_numbers": [ "Z-2582-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215606" }, { "event_id": "97443", "slug": "abbott", "firm": "Abbott Point Of Care Inc.", "class": "Class II", "initiated": "2025-08-21", "classified": "2025-09-17", "reported": "2025-09-24", "product": "i-STAT EG6+ cartridge. List Number: 03P77-25.", "products": 3, "reason": "Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.", "recall_numbers": [ "Z-2583-2025", "Z-2584-2025", "Z-2585-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215607" }, { "event_id": "97466", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2025-08-18", "classified": "2025-09-11", "reported": "2025-09-17", "product": "ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000", "products": 2, "reason": "Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.", "recall_numbers": [ "Z-2550-2025", "Z-2551-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215649" }, { "event_id": "97396", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2025-08-05", "classified": "2025-09-05", "reported": "2025-09-17", "product": "Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)", "products": 4, "reason": "The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.", "recall_numbers": [ "Z-2533-2025", "Z-2534-2025", "Z-2535-2025", "Z-2536-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215493" }, { "event_id": "97446", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2025-08-04", "classified": "2025-11-17", "reported": "2025-11-26", "product": "PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.", "products": 1, "reason": "Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.", "recall_numbers": [ "Z-0533-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215612" }, { "event_id": "97420", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2025-07-25", "classified": "2025-09-11", "reported": "2025-09-17", "product": "10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.", "products": 1, "reason": "Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.", "recall_numbers": [ "Z-2553-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215547" }, { "event_id": "96949", "slug": "stryker", "firm": "Physio-Control, Inc.", "class": "Class II", "initiated": "2025-07-22", "classified": "2025-09-02", "reported": "2025-09-10", "product": "LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.", "products": 3, "reason": "Due to required inspections not being performed on products/units that have gone through servicing.", "recall_numbers": [ "Z-2497-2025", "Z-2498-2025", "Z-2499-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214085" }, { "event_id": "97266", "slug": "medtronic", "firm": "Medtronic Xomed, Inc.", "class": "Class II", "initiated": "2025-07-17", "classified": "2025-08-27", "reported": "2025-09-03", "product": "IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and rods. The IPC is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.", "products": 1, "reason": "Due to out of the box wobble of the driver.", "recall_numbers": [ "Z-2461-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215013" }, { "event_id": "97285", "slug": "stryker", "firm": "Stryker Communications", "class": "Class II", "initiated": "2025-07-15", "classified": "2025-09-24", "reported": "2025-10-01", "product": "Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034", "products": 1, "reason": "Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.", "recall_numbers": [ "Z-2620-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215068" }, { "event_id": "97286", "slug": "biomerieux", "firm": "Biofire Defense", "class": "Class II", "initiated": "2025-07-10", "classified": "2025-09-19", "reported": "2025-10-01", "product": "FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.", "products": 1, "reason": "FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.", "recall_numbers": [ "Z-2609-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215069" }, { "event_id": "96916", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class II", "initiated": "2025-07-08", "classified": "2025-08-19", "reported": "2025-08-27", "product": "Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual", "products": 1, "reason": "Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.", "recall_numbers": [ "Z-2340-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214023" }, { "event_id": "97144", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class II", "initiated": "2025-07-08", "classified": "2025-09-12", "reported": "2025-09-24", "product": "Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09", "products": 1, "reason": "Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.", "recall_numbers": [ "Z-2558-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214651" }, { "event_id": "97133", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2025-07-02", "classified": "2025-08-07", "reported": "2025-08-13", "product": "Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235", "products": 1, "reason": "Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.", "recall_numbers": [ "Z-2277-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214628" }, { "event_id": "96890", "slug": "stryker", "firm": "HeartSine Technologies Ltd", "class": "Class II", "initiated": "2025-06-30", "classified": "2025-07-25", "reported": "2025-08-06", "product": "HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)", "products": 1, "reason": "Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)", "recall_numbers": [ "Z-2174-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213872" }, { "event_id": "97269", "slug": "biomerieux", "firm": "bioMerieux, Inc.", "class": "Class II", "initiated": "2025-06-26", "classified": "2025-09-29", "reported": "2025-10-08", "product": "VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only", "products": 1, "reason": "Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards", "recall_numbers": [ "Z-2671-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=215020" }, { "event_id": "97207", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2025-06-25", "classified": "2025-08-08", "reported": "2025-08-20", "product": "FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401", "products": 1, "reason": "The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.", "recall_numbers": [ "Z-2278-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214843" }, { "event_id": "96862", "slug": "medtronic", "firm": "Covidien", "class": "Class II", "initiated": "2025-06-23", "classified": "2025-07-21", "reported": "2025-07-30", "product": "Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN", "products": 1, "reason": "Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting", "recall_numbers": [ "Z-2151-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213817" }, { "event_id": "97039", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2025-06-18", "classified": "2025-07-23", "reported": "2025-07-30", "product": "Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip", "products": 2, "reason": "Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.", "recall_numbers": [ "Z-2170-2025", "Z-2171-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214314" }, { "event_id": "97130", "slug": "medtronic", "firm": "Medtronic, Inc.", "class": "Class II", "initiated": "2025-06-18", "classified": "2025-07-23", "reported": "2025-07-30", "product": "Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;", "products": 2, "reason": "In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.", "recall_numbers": [ "Z-2168-2025", "Z-2169-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214626" }, { "event_id": "97125", "slug": "medtronic", "firm": "Medtronic, Inc.", "class": "Class II", "initiated": "2025-06-17", "classified": "2025-07-17", "reported": "2025-07-23", "product": "Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.", "products": 2, "reason": "A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.", "recall_numbers": [ "Z-2127-2025", "Z-2128-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214616" }, { "event_id": "97237", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2025-06-16", "classified": "2025-09-02", "reported": "2025-09-10", "product": "InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)", "products": 1, "reason": "Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.", "recall_numbers": [ "Z-2496-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214940" }, { "event_id": "97036", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2025-06-10", "classified": "2025-07-10", "reported": "2025-07-16", "product": "Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.", "products": 4, "reason": "Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.", "recall_numbers": [ "Z-2103-2025", "Z-2104-2025", "Z-2105-2025", "Z-2106-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214302" }, { "event_id": "97109", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class II", "initiated": "2025-06-06", "classified": "2025-09-02", "reported": "2025-09-10", "product": "Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567 Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574 The Vertiflex Procedure Instrument Platform, VF Instrument 140-9800 00884662000611 The Superion IDS Kit includes a set of proprietary instruments to deliver the Superion Implant in a minimally invasive manner. Instruments specifically designed for implanting the Superion Implant are sterile, single-use disposable instruments, consisting of a Dilator Assembly, Cannula Assembly, Interspinous Gauge, Inserter, Reamer, and Driver.", "products": 1, "reason": "As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.", "recall_numbers": [ "Z-2485-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214586" }, { "event_id": "97151", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2025-06-05", "classified": "2025-08-12", "reported": "2025-08-20", "product": "Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B", "products": 4, "reason": "High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.", "recall_numbers": [ "Z-2293-2025", "Z-2294-2025", "Z-2295-2025", "Z-2296-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214670" }, { "event_id": "96927", "slug": "stryker", "firm": "Stryker GmbH", "class": "Class II", "initiated": "2025-05-28", "classified": "2025-06-06", "reported": "2025-06-18", "product": "Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.", "products": 1, "reason": "Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.", "recall_numbers": [ "Z-1914-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214048" }, { "event_id": "97045", "slug": "medtronic", "firm": "Medtronic Navigation, Inc.-Boxborough", "class": "Class II", "initiated": "2025-05-27", "classified": "2025-07-09", "reported": "2025-07-16", "product": "O-arm O2 Imaging System. Mobile X-Ray System.", "products": 1, "reason": "A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.", "recall_numbers": [ "Z-2101-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214321" }, { "event_id": "96924", "slug": "stryker", "firm": "Stryker GmbH", "class": "Class II", "initiated": "2025-05-22", "classified": "2025-06-10", "reported": "2025-06-18", "product": "Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.", "products": 2, "reason": "Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.", "recall_numbers": [ "Z-1939-2025", "Z-1940-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214043" }, { "event_id": "96729", "slug": "stryker", "firm": "Jolife AB", "class": "Class II", "initiated": "2025-05-21", "classified": "2025-06-20", "reported": "2025-07-02", "product": "LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.", "products": 1, "reason": "Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.", "recall_numbers": [ "Z-1998-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213480" }, { "event_id": "96925", "slug": "abbott", "firm": "BIGFOOT BIOMEDICAL", "class": "Class II", "initiated": "2025-05-21", "classified": "2025-06-20", "reported": "2025-07-02", "product": "Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.", "products": 1, "reason": "Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.", "recall_numbers": [ "Z-1997-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=214046" }, { "event_id": "96745", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2025-05-07", "classified": "2025-10-02", "reported": "2025-10-08", "product": "Medtronic, Simplera Sensor, REF: MMT-5100JD1", "products": 1, "reason": "The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.", "recall_numbers": [ "Z-0033-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213511" }, { "event_id": "96835", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2025-04-30", "classified": "2025-05-29", "reported": "2025-06-04", "product": "BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems", "products": 1, "reason": "Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.", "recall_numbers": [ "Z-1877-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213749" }, { "event_id": "96722", "slug": "medtronic", "firm": "Medtronic, Inc.", "class": "Class II", "initiated": "2025-04-29", "classified": "2025-06-06", "reported": "2025-06-18", "product": "Azure S DR MRI SureScan, Product number W3DR01", "products": 1, "reason": "Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.", "recall_numbers": [ "Z-1924-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213459" }, { "event_id": "96790", "slug": "abbott", "firm": "Abbott Molecular, Inc.", "class": "Class II", "initiated": "2025-04-28", "classified": "2025-05-12", "reported": "2025-05-21", "product": "Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.", "products": 2, "reason": "There were reports of an increase in reactive negative controls and false positive results.", "recall_numbers": [ "Z-1748-2025", "Z-1749-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213670" }, { "event_id": "96621", "slug": "roche", "firm": "Foundation Medicine, Inc.", "class": "Class II", "initiated": "2025-04-09", "classified": "2025-05-12", "reported": "2025-05-21", "product": "FoundationOne Companion Diagnostic (F1CDx)", "products": 1, "reason": "Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.", "recall_numbers": [ "Z-1747-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213277" }, { "event_id": "96682", "slug": "stryker", "firm": "Inari Medical - Oak Canyon", "class": "Class II", "initiated": "2025-04-08", "classified": "2025-05-06", "reported": "2025-05-14", "product": "Artix MT Thrombectomy Device, REF: 32-102", "products": 1, "reason": "Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.", "recall_numbers": [ "Z-1728-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213396" }, { "event_id": "96688", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2025-04-03", "classified": "2025-04-30", "reported": "2025-05-07", "product": "Enhanced Verify Evaluation Handset (CFN HH90130FA)", "products": 1, "reason": "Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.", "recall_numbers": [ "Z-1704-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213404" }, { "event_id": "96555", "slug": "stryker", "firm": "Stryker GmbH", "class": "Class II", "initiated": "2025-03-28", "classified": "2025-04-17", "reported": "2025-04-23", "product": "Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;", "products": 2, "reason": "The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.", "recall_numbers": [ "Z-1620-2025", "Z-1621-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213155" }, { "event_id": "96556", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2025-03-24", "classified": "2025-04-29", "reported": "2025-05-07", "product": "IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.", "products": 4, "reason": "Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.", "recall_numbers": [ "Z-1686-2025", "Z-1687-2025", "Z-1688-2025", "Z-1689-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213157" }, { "event_id": "96559", "slug": "abbott", "firm": "Abbott Molecular, Inc.", "class": "Class II", "initiated": "2025-03-20", "classified": "2025-04-24", "reported": "2025-04-30", "product": "The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).", "products": 1, "reason": "The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.", "recall_numbers": [ "Z-1665-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213165" }, { "event_id": "96567", "slug": "abbott", "firm": "Abbott Laboratories", "class": "Class II", "initiated": "2025-03-18", "classified": "2025-04-22", "reported": "2025-04-30", "product": "Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No", "products": 5, "reason": "When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.", "recall_numbers": [ "Z-1652-2025", "Z-1653-2025", "Z-1654-2025", "Z-1655-2025", "Z-1656-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213179" }, { "event_id": "96545", "slug": "abbott", "firm": "Abbott", "class": "Class II", "initiated": "2025-03-17", "classified": "2025-04-21", "reported": "2025-04-30", "product": "Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080", "products": 2, "reason": "Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.", "recall_numbers": [ "Z-1643-2025", "Z-1644-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213141" }, { "event_id": "96482", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2025-03-14", "classified": "2025-04-21", "reported": "2025-04-30", "product": "Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly", "products": 2, "reason": "Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.", "recall_numbers": [ "Z-1640-2025", "Z-1641-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213016" }, { "event_id": "96511", "slug": "medtronic", "firm": "Medtronic Xomed, Inc.", "class": "Class II", "initiated": "2025-03-10", "classified": "2025-04-18", "reported": "2025-04-30", "product": "NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4, REF: NIM4SWU154; SOFTWARE NIM4SWU164 UPGRADE V1.6.4, REF: NIM4SWU164", "products": 1, "reason": "Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.", "recall_numbers": [ "Z-1623-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213082" }, { "event_id": "96421", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2025-03-04", "classified": "2025-04-21", "reported": "2025-04-30", "product": "InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA", "products": 1, "reason": "Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.", "recall_numbers": [ "Z-1650-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212825" }, { "event_id": "96445", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2025-03-04", "classified": "2025-04-08", "reported": "2025-04-16", "product": "Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators", "products": 1, "reason": "There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.", "recall_numbers": [ "Z-1543-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212886" }, { "event_id": "96500", "slug": "abbott", "firm": "Abbott Diagnostics Scarborough, Inc.", "class": "Class II", "initiated": "2025-03-04", "classified": "2025-04-15", "reported": "2025-04-23", "product": "Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No", "products": 3, "reason": "the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.", "recall_numbers": [ "Z-1574-2025", "Z-1575-2025", "Z-1576-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213033" }, { "event_id": "96519", "slug": "abbott", "firm": "Abbott Diagnostics Scarborough, Inc.", "class": "Class II", "initiated": "2025-03-04", "classified": "2025-04-15", "reported": "2025-04-23", "product": "Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No", "products": 3, "reason": "The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.", "recall_numbers": [ "Z-1571-2025", "Z-1572-2025", "Z-1573-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213090" }, { "event_id": "96494", "slug": "stryker", "firm": "Tornier, Inc", "class": "Class II", "initiated": "2025-03-03", "classified": "2025-04-22", "reported": "2025-04-30", "product": "stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented", "products": 1, "reason": "A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. \" Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) \" Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)", "recall_numbers": [ "Z-1651-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213028" }, { "event_id": "96349", "slug": "stryker", "firm": "Stryker Spine", "class": "Class II", "initiated": "2025-02-28", "classified": "2025-03-31", "reported": "2025-04-09", "product": "Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.", "products": 4, "reason": "Potential for the gold unlock button to separate from the inserter.", "recall_numbers": [ "Z-1488-2025", "Z-1489-2025", "Z-1490-2025", "Z-1491-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212607" }, { "event_id": "96346", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2025-02-27", "classified": "2025-04-04", "reported": "2025-04-16", "product": "FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374", "products": 1, "reason": "Increased risk of control failures and false negative test results with multiplexed nucleic acid test.", "recall_numbers": [ "Z-1518-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212805" }, { "event_id": "96393", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2025-02-25", "classified": "2025-03-28", "reported": "2025-04-09", "product": "Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL", "products": 14, "reason": "There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.", "recall_numbers": [ "Z-1469-2025", "Z-1470-2025", "Z-1471-2025", "Z-1472-2025", "Z-1473-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212759" }, { "event_id": "96309", "slug": "medtronic", "firm": "Oridion Medical 1987 Ltd.", "class": "Class II", "initiated": "2025-02-17", "classified": "2025-03-17", "reported": "2025-03-26", "product": "Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology Length 7 (2.0 m), XS04620COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), XS04624COV", "products": 10, "reason": "Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.", "recall_numbers": [ "Z-1376-2025", "Z-1377-2025", "Z-1378-2025", "Z-1379-2025", "Z-1380-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212534" }, { "event_id": "96411", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2025-02-15", "classified": "2025-04-14", "reported": "2025-04-23", "product": "Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.", "products": 1, "reason": "Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.", "recall_numbers": [ "Z-1557-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212807" }, { "event_id": "96095", "slug": "stryker", "firm": "Physio-Control, Inc.", "class": "Class II", "initiated": "2025-02-03", "classified": "2025-02-25", "reported": "2025-03-05", "product": "LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.", "products": 1, "reason": "Incorrect keypad was incorrectly installed onto a defibrillator/monitor.", "recall_numbers": [ "Z-1232-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211995" }, { "event_id": "96326", "slug": "abbott", "firm": "St. Jude Medical", "class": "Class II", "initiated": "2025-02-03", "classified": "2025-03-21", "reported": "2025-04-02", "product": "CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS\" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.", "products": 1, "reason": "Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.", "recall_numbers": [ "Z-1427-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212553" }, { "event_id": "96200", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2025-01-31", "classified": "2025-03-03", "reported": "2025-03-12", "product": "MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)", "products": 12, "reason": "All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.", "recall_numbers": [ "Z-1255-2025", "Z-1256-2025", "Z-1257-2025", "Z-1258-2025", "Z-1259-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212321" }, { "event_id": "96281", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2025-01-29", "classified": "2025-03-12", "reported": "2025-03-19", "product": "Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197", "products": 1, "reason": "Increase in complaints concerning \"pullwire\" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.", "recall_numbers": [ "Z-1328-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212471" }, { "event_id": "96292", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2025-01-27", "classified": "2025-03-24", "reported": "2025-04-02", "product": "Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D", "products": 1, "reason": "Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.", "recall_numbers": [ "Z-1434-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212497" }, { "event_id": "95766", "slug": "stryker", "firm": "Physio-Control, Inc.", "class": "Class II", "initiated": "2025-01-21", "classified": "2025-02-19", "reported": "2025-02-26", "product": "LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK¿ 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow\" 8¿ SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO¿), and methemoglobin saturation (SpMet¿) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.", "products": 1, "reason": "Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.", "recall_numbers": [ "Z-1184-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211134" }, { "event_id": "96048", "slug": "stryker", "firm": "Physio-Control, Inc.", "class": "Class II", "initiated": "2025-01-21", "classified": "2025-02-05", "reported": "2025-02-12", "product": "LIFEPAK 35 ECG cable REF 11111-000041", "products": 1, "reason": "Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions", "recall_numbers": [ "Z-1102-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211857" }, { "event_id": "96237", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2025-01-09", "classified": "2025-04-01", "reported": "2025-04-09", "product": "A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.", "products": 1, "reason": "Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.", "recall_numbers": [ "Z-1506-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=212397" }, { "event_id": "96098", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2025-01-08", "classified": "2025-02-11", "reported": "2025-02-19", "product": "stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades", "products": 2, "reason": "Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.", "recall_numbers": [ "Z-1138-2025", "Z-1139-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211998" }, { "event_id": "96049", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-12-20", "classified": "2025-01-30", "reported": "2025-02-05", "product": "AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740", "products": 14, "reason": "Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.", "recall_numbers": [ "Z-1024-2025", "Z-1025-2025", "Z-1026-2025", "Z-1027-2025", "Z-1028-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211858" }, { "event_id": "96015", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2024-12-12", "classified": "2025-01-17", "reported": "2025-01-29", "product": "DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)", "products": 3, "reason": "Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.", "recall_numbers": [ "Z-0984-2025", "Z-0985-2025", "Z-0986-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211789" }, { "event_id": "95970", "slug": "medtronic", "firm": "Medtronic Navigation, Inc.", "class": "Class II", "initiated": "2024-12-04", "classified": "2025-01-27", "reported": "2025-02-05", "product": "Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system.", "products": 1, "reason": "Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.", "recall_numbers": [ "Z-1022-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211670" }, { "event_id": "95856", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2024-12-03", "classified": "2025-01-06", "reported": "2025-01-15", "product": "100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)", "products": 1, "reason": "Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.", "recall_numbers": [ "Z-0807-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211411" }, { "event_id": "95957", "slug": "medtronic", "firm": "Medicrea International", "class": "Class II", "initiated": "2024-12-03", "classified": "2025-02-06", "reported": "2025-02-12", "product": "UNiD\" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.", "products": 1, "reason": "Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.", "recall_numbers": [ "Z-1118-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211640" }, { "event_id": "95813", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2024-11-21", "classified": "2024-12-23", "reported": "2025-01-01", "product": "The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.", "products": 1, "reason": "Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a \u001closs of telemetry detected\u001d window, and there is no pacing.", "recall_numbers": [ "Z-0753-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211301" }, { "event_id": "95845", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-11-21", "classified": "2024-12-27", "reported": "2025-01-08", "product": "SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D", "products": 4, "reason": "Software issues were identified in application version 2.x.", "recall_numbers": [ "Z-0771-2025", "Z-0772-2025", "Z-0773-2025", "Z-0774-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=211344" }, { "event_id": "95706", "slug": "abbott", "firm": "St. Jude Medical", "class": "Class II", "initiated": "2024-11-06", "classified": "2025-01-17", "reported": "2025-01-29", "product": "Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS\" Hospital System model CM3100) The CardioMEMS\" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.", "products": 1, "reason": "Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings.", "recall_numbers": [ "Z-0987-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210981" }, { "event_id": "95707", "slug": "abbott", "firm": "Abbott Vascular Inc", "class": "Class II", "initiated": "2024-11-06", "classified": "2024-12-20", "reported": "2025-01-01", "product": "20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.", "products": 4, "reason": "Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.", "recall_numbers": [ "Z-0730-2025", "Z-0731-2025", "Z-0732-2025", "Z-0733-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210982" }, { "event_id": "95608", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-10-28", "classified": "2024-11-25", "reported": "2024-12-04", "product": "AMS Artificial Urinary Sphincter Control Pump", "products": 2, "reason": "Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)", "recall_numbers": [ "Z-0530-2025", "Z-0531-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210762" }, { "event_id": "95609", "slug": "roche", "firm": "Roche Diagnostics Operations, Inc.", "class": "Class II", "initiated": "2024-10-17", "classified": "2024-11-19", "reported": "2024-11-27", "product": "cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine", "products": 1, "reason": "Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)", "recall_numbers": [ "Z-0489-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210764" }, { "event_id": "95627", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2024-10-17", "classified": "2024-11-20", "reported": "2024-11-27", "product": "Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile", "products": 5, "reason": "A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.", "recall_numbers": [ "Z-0491-2025", "Z-0492-2025", "Z-0493-2025", "Z-0494-2025", "Z-0495-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210825" }, { "event_id": "95602", "slug": "abbott", "firm": "St. Jude Medical", "class": "Class II", "initiated": "2024-10-05", "classified": "2025-01-17", "reported": "2025-01-29", "product": "CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000", "products": 2, "reason": "As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.", "recall_numbers": [ "Z-0988-2025", "Z-0989-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210751" }, { "event_id": "95502", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2024-10-04", "classified": "2024-11-13", "reported": "2024-11-20", "product": "Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-047-000", "products": 6, "reason": "There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries", "recall_numbers": [ "Z-0365-2025", "Z-0366-2025", "Z-0367-2025", "Z-0368-2025", "Z-0369-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210433" }, { "event_id": "95507", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2024-10-03", "classified": "2024-11-04", "reported": "2024-11-13", "product": "Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery", "products": 1, "reason": "There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal", "recall_numbers": [ "Z-0289-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210448" }, { "event_id": "95489", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-09-24", "classified": "2024-10-23", "reported": "2024-10-30", "product": "Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.", "products": 1, "reason": "A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an \"Invalid Device\" message will appear.", "recall_numbers": [ "Z-0206-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210373" }, { "event_id": "95447", "slug": "medtronic", "firm": "Covidien LP", "class": "Class II", "initiated": "2024-09-19", "classified": "2024-10-29", "reported": "2024-11-06", "product": "Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)", "products": 1, "reason": "Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.", "recall_numbers": [ "Z-0257-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210304" }, { "event_id": "95465", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-09-18", "classified": "2024-11-13", "reported": "2024-11-20", "product": "Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system", "products": 1, "reason": "The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.", "recall_numbers": [ "Z-0372-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210340" }, { "event_id": "95442", "slug": "abbott", "firm": "Abbott Molecular, Inc.", "class": "Class II", "initiated": "2024-09-12", "classified": "2024-10-28", "reported": "2024-11-06", "product": "Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091", "products": 2, "reason": "Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.", "recall_numbers": [ "Z-0233-2025", "Z-0234-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210296" }, { "event_id": "95419", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-09-11", "classified": "2024-10-21", "reported": "2024-10-30", "product": "SynchroMed II Infusion Pump. Product Number: 8637-20", "products": 1, "reason": "Potential for error and inability to interrogate pump due to data corruption in the pump memory.", "recall_numbers": [ "Z-0137-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210208" }, { "event_id": "95441", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-09-06", "classified": "2024-10-24", "reported": "2024-10-30", "product": "Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.", "products": 1, "reason": "Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.", "recall_numbers": [ "Z-0226-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210294" }, { "event_id": "95331", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-09-05", "classified": "2024-10-16", "reported": "2024-10-23", "product": "Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral vascular imaging catheter, the system utilizes the IVUS modality for ultrasound examination of intravascular pathology.", "products": 22, "reason": "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters. This software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.", "recall_numbers": [ "Z-0095-2025", "Z-0096-2025", "Z-0097-2025", "Z-0098-2025", "Z-0099-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209999" }, { "event_id": "95342", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2024-09-05", "classified": "2024-10-11", "reported": "2024-10-23", "product": "1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012", "products": 1, "reason": "May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.", "recall_numbers": [ "Z-0063-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210037" }, { "event_id": "95315", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2024-09-04", "classified": "2024-10-07", "reported": "2024-10-16", "product": "Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200", "products": 1, "reason": "Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.", "recall_numbers": [ "Z-0023-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209970" }, { "event_id": "95314", "slug": "stryker", "firm": "Stryker Neurovascular", "class": "Class II", "initiated": "2024-08-30", "classified": "2024-10-07", "reported": "2024-10-16", "product": "The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.", "products": 1, "reason": "Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.", "recall_numbers": [ "Z-0021-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209969" }, { "event_id": "95330", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2024-08-30", "classified": "2024-10-11", "reported": "2024-10-23", "product": "Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.", "products": 6, "reason": "Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.", "recall_numbers": [ "Z-0057-2025", "Z-0058-2025", "Z-0059-2025", "Z-0060-2025", "Z-0061-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209993" }, { "event_id": "95373", "slug": "stryker", "firm": "Physio-Control, Inc.", "class": "Class II", "initiated": "2024-08-30", "classified": "2024-10-25", "reported": "2024-11-06", "product": "LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.", "products": 1, "reason": "Due to an out of tolerance tool being used on monitor/defibrillator systems.", "recall_numbers": [ "Z-0230-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210079" }, { "event_id": "95245", "slug": "stryker", "firm": "Tornier, Inc", "class": "Class II", "initiated": "2024-08-29", "classified": "2024-09-27", "reported": "2024-10-09", "product": "Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty", "products": 1, "reason": "Devices from one lot of Perform\" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.", "recall_numbers": [ "Z-3309-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209806" }, { "event_id": "95258", "slug": "stryker", "firm": "Tornier, Inc", "class": "Class II", "initiated": "2024-08-29", "classified": "2024-09-16", "reported": "2024-09-25", "product": "stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder", "products": 1, "reason": "One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).", "recall_numbers": [ "Z-3155-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209832" }, { "event_id": "95274", "slug": "stryker", "firm": "Stryker Spine", "class": "Class II", "initiated": "2024-08-23", "classified": "2024-09-23", "reported": "2024-10-02", "product": "AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.", "products": 1, "reason": "Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.", "recall_numbers": [ "Z-3210-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209874" }, { "event_id": "95283", "slug": "medtronic", "firm": "Medtronic Navigation, Inc.", "class": "Class II", "initiated": "2024-08-22", "classified": "2024-10-10", "reported": "2024-10-16", "product": "StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.", "products": 1, "reason": "Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.", "recall_numbers": [ "Z-0050-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209896" }, { "event_id": "95281", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-08-21", "classified": "2024-10-17", "reported": "2024-10-23", "product": "Vanta Implantable Neurostimulator (INS), Model 977006", "products": 1, "reason": "Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.", "recall_numbers": [ "Z-0132-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209893" }, { "event_id": "95343", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2024-08-19", "classified": "2024-10-11", "reported": "2024-10-23", "product": "basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C", "products": 10, "reason": "Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.", "recall_numbers": [ "Z-0064-2025", "Z-0065-2025", "Z-0066-2025", "Z-0067-2025", "Z-0068-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210038" }, { "event_id": "95221", "slug": "roche", "firm": "Roche Diagnostics Operations, Inc.", "class": "Class II", "initiated": "2024-08-15", "classified": "2024-09-20", "reported": "2024-10-02", "product": "Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190", "products": 1, "reason": "Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.", "recall_numbers": [ "Z-3187-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209761" }, { "event_id": "95234", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2024-08-12", "classified": "2024-09-20", "reported": "2024-10-02", "product": "Custom Procedure Kit, REF: K12T-11077", "products": 2, "reason": "7F sheath introducers labeled as 7.5F", "recall_numbers": [ "Z-3190-2024", "Z-3191-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209788" }, { "event_id": "95242", "slug": "stryker", "firm": "Physio-Control, Inc.", "class": "Class II", "initiated": "2024-08-09", "classified": "2024-10-22", "reported": "2024-10-30", "product": "STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.", "products": 1, "reason": "Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.", "recall_numbers": [ "Z-0142-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209803" }, { "event_id": "95019", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2024-08-07", "classified": "2024-09-11", "reported": "2024-09-18", "product": "FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W", "products": 2, "reason": "Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that may lead modules and instruments to report higher melting temperatures, which may lead to erroneous results including false positive Salmonella, Giardia lamblia, false positive/negative Norovirus, and false negative MRSA.", "recall_numbers": [ "Z-3122-2024", "Z-3123-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209116" }, { "event_id": "95277", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2024-08-07", "classified": "2024-10-09", "reported": "2024-10-16", "product": "MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063", "products": 1, "reason": "Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.", "recall_numbers": [ "Z-0044-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209889" }, { "event_id": "95114", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2024-08-05", "classified": "2024-08-26", "reported": "2024-09-04", "product": "Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;", "products": 1, "reason": "A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.", "recall_numbers": [ "Z-2732-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209479" }, { "event_id": "95124", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-08-01", "classified": "2024-09-26", "reported": "2024-10-02", "product": "WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516270", "products": 31, "reason": "WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.", "recall_numbers": [ "Z-3265-2024", "Z-3266-2024", "Z-3267-2024", "Z-3268-2024", "Z-3269-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209507" }, { "event_id": "95040", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2024-07-24", "classified": "2024-08-26", "reported": "2024-09-04", "product": "Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-013-030DC", "products": 10, "reason": "Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.", "recall_numbers": [ "Z-2722-2024", "Z-2723-2024", "Z-2724-2024", "Z-2725-2024", "Z-2726-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209183" }, { "event_id": "95139", "slug": "stryker", "firm": "TMJ Solutions Inc", "class": "Class II", "initiated": "2024-07-24", "classified": "2024-09-26", "reported": "2024-10-02", "product": "Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.", "products": 1, "reason": "Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO", "recall_numbers": [ "Z-3264-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209567" }, { "event_id": "95186", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-07-18", "classified": "2024-09-13", "reported": "2024-09-25", "product": "VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.", "products": 5, "reason": "There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.", "recall_numbers": [ "Z-3147-2024", "Z-3148-2024", "Z-3149-2024", "Z-3150-2024", "Z-3151-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209691" }, { "event_id": "94995", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class II", "initiated": "2024-07-17", "classified": "2024-08-14", "reported": "2024-08-21", "product": "WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320", "products": 1, "reason": "Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.", "recall_numbers": [ "Z-2617-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209084" }, { "event_id": "95189", "slug": "medtronic", "firm": "Mazor Robotics Ltd", "class": "Class II", "initiated": "2024-07-17", "classified": "2024-09-16", "reported": "2024-09-25", "product": "Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument", "products": 1, "reason": "Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.", "recall_numbers": [ "Z-3156-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209698" }, { "event_id": "95176", "slug": "medtronic", "firm": "Medtronic Inc.", "class": "Class II", "initiated": "2024-07-11", "classified": "2024-09-13", "reported": "2024-09-25", "product": "2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT", "products": 1, "reason": "Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.", "recall_numbers": [ "Z-3152-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209676" }, { "event_id": "95032", "slug": "medtronic", "firm": "Covidien", "class": "Class II", "initiated": "2024-07-09", "classified": "2024-08-22", "reported": "2024-08-28", "product": "Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly", "products": 1, "reason": "IFU update to address device's battery handling information.", "recall_numbers": [ "Z-2717-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209145" }, { "event_id": "95152", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2024-07-09", "classified": "2024-09-12", "reported": "2024-09-18", "product": "Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312", "products": 1, "reason": "During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).", "recall_numbers": [ "Z-3128-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209609" }, { "event_id": "95162", "slug": "medtronic", "firm": "Medtronic Xomed, Inc.", "class": "Class II", "initiated": "2024-07-05", "classified": "2024-09-12", "reported": "2024-09-18", "product": "Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069", "products": 1, "reason": "Product was distributed past expiration date.", "recall_numbers": [ "Z-3130-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209635" }, { "event_id": "95038", "slug": "stryker", "firm": "Stryker Sustainability Solutions", "class": "Class II", "initiated": "2024-07-02", "classified": "2024-08-20", "reported": "2024-08-28", "product": "Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A", "products": 1, "reason": "Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.", "recall_numbers": [ "Z-2689-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209175" }, { "event_id": "94921", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-06-27", "classified": "2024-07-30", "reported": "2024-08-07", "product": "Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.", "products": 2, "reason": "Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.", "recall_numbers": [ "Z-2451-2024", "Z-2452-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208819" }, { "event_id": "94985", "slug": "roche", "firm": "Ventana Medical Systems, Inc.", "class": "Class II", "initiated": "2024-06-27", "classified": "2024-08-16", "reported": "2024-08-28", "product": "Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD", "products": 1, "reason": "Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.", "recall_numbers": [ "Z-2644-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209033" }, { "event_id": "94973", "slug": "abbott", "firm": "Thoratec LLC", "class": "Class II", "initiated": "2024-06-25", "classified": "2024-08-13", "reported": "2024-08-21", "product": "HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3 System Controller, OUS, Model: 106531INT; HeartMate 3 System Controller Low Flow 2.0, Global, Model: 106531LF2", "products": 1, "reason": "Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop", "recall_numbers": [ "Z-2583-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208997" }, { "event_id": "94871", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2024-06-19", "classified": "2024-07-16", "reported": "2024-07-24", "product": "UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043", "products": 3, "reason": "Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)", "recall_numbers": [ "Z-2370-2024", "Z-2371-2024", "Z-2372-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208513" }, { "event_id": "94886", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2024-06-19", "classified": "2024-07-31", "reported": "2024-08-07", "product": "BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853", "products": 1, "reason": "If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.", "recall_numbers": [ "Z-2456-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208596" }, { "event_id": "96802", "slug": "roche", "firm": "Foundation Medicine, Inc.", "class": "Class II", "initiated": "2024-06-18", "classified": "2025-05-30", "reported": "2025-06-11", "product": "FoundationOne Companion Diagnostic (F1CDx)", "products": 1, "reason": "Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.", "recall_numbers": [ "Z-1890-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=213697" }, { "event_id": "94910", "slug": "abbott", "firm": "Abbott Diagnostics Technologies AS", "class": "Class II", "initiated": "2024-06-17", "classified": "2024-08-27", "reported": "2024-09-04", "product": "Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.", "products": 1, "reason": "Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.", "recall_numbers": [ "Z-2736-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208893" }, { "event_id": "95131", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-06-17", "classified": "2024-09-06", "reported": "2024-09-18", "product": "Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.", "products": 1, "reason": "A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.", "recall_numbers": [ "Z-3073-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209554" }, { "event_id": "94958", "slug": "abbott", "firm": "Abbott Laboratories", "class": "Class II", "initiated": "2024-06-14", "classified": "2024-08-16", "reported": "2024-08-28", "product": "Alinity hq Analyzer, REF: 09P68-01", "products": 1, "reason": "1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts", "recall_numbers": [ "Z-2681-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208939" }, { "event_id": "94827", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-06-12", "classified": "2024-07-12", "reported": "2024-07-24", "product": "Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.", "products": 1, "reason": "Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.", "recall_numbers": [ "Z-2350-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208444" }, { "event_id": "94797", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2024-06-11", "classified": "2024-08-12", "reported": "2024-08-21", "product": "Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.", "products": 23, "reason": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.", "recall_numbers": [ "Z-2557-2024", "Z-2558-2024", "Z-2559-2024", "Z-2560-2024", "Z-2561-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208431" }, { "event_id": "94942", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2024-06-10", "classified": "2024-08-16", "reported": "2024-08-28", "product": "BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143", "products": 2, "reason": "Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.", "recall_numbers": [ "Z-2682-2024", "Z-2683-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208857" }, { "event_id": "94755", "slug": "stryker", "firm": "Stryker Corporation", "class": "Class II", "initiated": "2024-06-03", "classified": "2024-07-03", "reported": "2024-07-10", "product": "The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers the helmet and air is drawn into the helmet through a filter located on the top-backside of the hood. The filtered air is delivered into the helmet and the disposable does not inhibit adjustment of helmet settings/functions. Catalog Number: 0408-800-000NS", "products": 3, "reason": "Expired Products distributed to customers", "recall_numbers": [ "Z-2259-2024", "Z-2260-2024", "Z-2261-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208193" }, { "event_id": "94824", "slug": "stryker", "firm": "Stryker Sustainability Solutions", "class": "Class II", "initiated": "2024-05-31", "classified": "2024-07-17", "reported": "2024-07-24", "product": "REF: 60-7070-005, Zimmer, Tourniquet Cuff 30\" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly", "products": 1, "reason": "Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.", "recall_numbers": [ "Z-2405-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208443" }, { "event_id": "94909", "slug": "artivion", "firm": "Artivion, Inc", "class": "Class II", "initiated": "2024-05-28", "classified": "2024-08-08", "reported": "2024-08-14", "product": "(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.", "products": 2, "reason": "Grafts were found to have been approved, released, shipped and implanted with an invalid test results.", "recall_numbers": [ "Z-2531-2024", "Z-2532-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208844" }, { "event_id": "94708", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2024-05-23", "classified": "2024-06-18", "reported": "2024-06-26", "product": "Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910", "products": 2, "reason": "The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.", "recall_numbers": [ "Z-2152-2024", "Z-2153-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208059" }, { "event_id": "94588", "slug": "abbott", "firm": "Thoratec Switzerland GMBH", "class": "Class II", "initiated": "2024-05-22", "classified": "2024-06-27", "reported": "2024-07-03", "product": "2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System", "products": 1, "reason": "Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.", "recall_numbers": [ "Z-2215-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207617" }, { "event_id": "94684", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2024-05-22", "classified": "2024-06-27", "reported": "2024-07-03", "product": "Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP -PG7F45MPX -PG7F45RX -PG7F45S -PG7F45SX -PG7F65SX -PG7F90SX -PG8F45MPX -PG8F45S -PG8F45SX -PG8F65SX -PG8F90SX -X9PG700001 The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.", "products": 1, "reason": "Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.", "recall_numbers": [ "Z-2218-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207999" }, { "event_id": "94796", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2024-05-22", "classified": "2024-07-25", "reported": "2024-07-31", "product": "Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only", "products": 4, "reason": "Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.", "recall_numbers": [ "Z-2429-2024", "Z-2430-2024", "Z-2431-2024", "Z-2432-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208346" }, { "event_id": "94747", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2024-05-16", "classified": "2024-07-03", "reported": "2024-07-10", "product": "Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY", "products": 1, "reason": "Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.", "recall_numbers": [ "Z-2265-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208166" }, { "event_id": "94798", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2024-05-16", "classified": "2024-07-16", "reported": "2024-07-24", "product": "Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only", "products": 12, "reason": "The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.", "recall_numbers": [ "Z-2358-2024", "Z-2359-2024", "Z-2360-2024", "Z-2361-2024", "Z-2362-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208350" }, { "event_id": "94856", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2024-05-16", "classified": "2024-07-23", "reported": "2024-07-31", "product": "TourniKwik Tourniquet Set (CFN 79012)", "products": 1, "reason": "Incorrect component placed in four manufactured lots of the TourniKwik\" Tourniquet Set.", "recall_numbers": [ "Z-2423-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208493" }, { "event_id": "94992", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2024-05-16", "classified": "2024-08-06", "reported": "2024-08-14", "product": "BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.", "products": 1, "reason": "Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.", "recall_numbers": [ "Z-2514-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=209080" }, { "event_id": "94845", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-05-15", "classified": "2024-07-24", "reported": "2024-07-31", "product": "A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1", "products": 1, "reason": "Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.", "recall_numbers": [ "Z-2427-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208483" }, { "event_id": "94655", "slug": "roche", "firm": "Roche Diabetes Care, Inc.", "class": "Class II", "initiated": "2024-05-13", "classified": "2024-06-21", "reported": "2024-07-03", "product": "Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. Product REF Number: 08453071001", "products": 1, "reason": "The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.", "recall_numbers": [ "Z-2174-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207936" }, { "event_id": "94726", "slug": "stryker", "firm": "Stryker Sustainability Solutions", "class": "Class II", "initiated": "2024-05-10", "classified": "2024-07-03", "reported": "2024-07-10", "product": "Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only", "products": 1, "reason": "Diagnostic electrophysiology (EP) catheters do not meet testing requirements.", "recall_numbers": [ "Z-2268-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208112" }, { "event_id": "94779", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-05-10", "classified": "2024-07-12", "reported": "2024-07-24", "product": "Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)", "products": 1, "reason": "Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.", "recall_numbers": [ "Z-2352-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208260" }, { "event_id": "94721", "slug": "stryker", "firm": "Stryker GmbH", "class": "Class II", "initiated": "2024-05-09", "classified": "2024-06-27", "reported": "2024-07-03", "product": "Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.", "products": 1, "reason": "The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.", "recall_numbers": [ "Z-2219-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=208107" }, { "event_id": "94613", "slug": "abbott", "firm": "St. Jude Medical", "class": "Class II", "initiated": "2024-04-30", "classified": "2024-07-12", "reported": "2024-07-24", "product": "St. Jude Medical Agilis NxT Steerable Introducer, REF 408309", "products": 1, "reason": "One lot of product has dilators that are too short and will not extend outside the introducer sheath.", "recall_numbers": [ "Z-2348-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207733" }, { "event_id": "94566", "slug": "medtronic", "firm": "Medtronic Navigation, Inc.-Littleton", "class": "Class II", "initiated": "2024-04-26", "classified": "2024-06-06", "reported": "2024-06-12", "product": "O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000", "products": 1, "reason": "Potential for an electrical component of the O-arm\" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.", "recall_numbers": [ "Z-2026-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207582" }, { "event_id": "94541", "slug": "medtronic", "firm": "Covidien, LLC", "class": "Class II", "initiated": "2024-04-25", "classified": "2024-06-07", "reported": "2024-06-19", "product": "EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only", "products": 1, "reason": "Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.", "recall_numbers": [ "Z-2038-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207541" }, { "event_id": "94437", "slug": "stryker", "firm": "Stryker Neurovascular", "class": "Class II", "initiated": "2024-04-23", "classified": "2024-05-28", "reported": "2024-06-05", "product": "Trevo ProVue, Catalog: 90184", "products": 8, "reason": "Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.", "recall_numbers": [ "Z-1902-2024", "Z-1903-2024", "Z-1904-2024", "Z-1905-2024", "Z-1906-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207220" }, { "event_id": "94377", "slug": "boston-scientific", "firm": "Boston Scientific Neuromodulation Corporation", "class": "Class II", "initiated": "2024-04-18", "classified": "2024-05-24", "reported": "2024-06-05", "product": "Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320", "products": 1, "reason": "Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.", "recall_numbers": [ "Z-1890-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207089" }, { "event_id": "94543", "slug": "stryker", "firm": "Stryker Neurovascular", "class": "Class II", "initiated": "2024-04-18", "classified": "2024-05-31", "reported": "2024-06-12", "product": "The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque.", "products": 3, "reason": "Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.", "recall_numbers": [ "Z-1939-2024", "Z-1940-2024", "Z-1941-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207540" }, { "event_id": "94674", "slug": "medtronic", "firm": "Medtronic Inc.", "class": "Class II", "initiated": "2024-04-16", "classified": "2024-06-26", "reported": "2024-07-03", "product": "EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator", "products": 23, "reason": "Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.", "recall_numbers": [ "Z-2190-2024", "Z-2191-2024", "Z-2192-2024", "Z-2193-2024", "Z-2194-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207969" }, { "event_id": "94473", "slug": "stryker", "firm": "Stryker Orthopaedics", "class": "Class II", "initiated": "2024-04-15", "classified": "2024-05-28", "reported": "2024-06-05", "product": "Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01", "products": 6, "reason": "Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment", "recall_numbers": [ "Z-1910-2024", "Z-1911-2024", "Z-1912-2024", "Z-1913-2024", "Z-1914-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207273" }, { "event_id": "94484", "slug": "medtronic", "firm": "Covidien, LP", "class": "Class II", "initiated": "2024-04-15", "classified": "2024-05-24", "reported": "2024-06-05", "product": "Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT", "products": 1, "reason": "Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery", "recall_numbers": [ "Z-1891-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207293" }, { "event_id": "94076", "slug": "stryker", "firm": "HeartSine Technologies Ltd", "class": "Class II", "initiated": "2024-04-08", "classified": "2024-05-14", "reported": "2024-05-22", "product": "HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P", "products": 1, "reason": "Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.", "recall_numbers": [ "Z-1820-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206255" }, { "event_id": "94456", "slug": "stryker", "firm": "Stryker Leibinger GmbH & Co. KG", "class": "Class II", "initiated": "2024-04-04", "classified": "2024-05-23", "reported": "2024-05-29", "product": "8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.", "products": 1, "reason": "Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.", "recall_numbers": [ "Z-1885-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207243" }, { "event_id": "94347", "slug": "stryker", "firm": "Stryker Neurovascular", "class": "Class II", "initiated": "2024-04-03", "classified": "2024-05-01", "reported": "2024-05-08", "product": "The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.", "products": 1, "reason": "Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.", "recall_numbers": [ "Z-1740-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206975" }, { "event_id": "94367", "slug": "stryker", "firm": "Stryker Leibinger GmbH & Co. KG", "class": "Class II", "initiated": "2024-03-29", "classified": "2024-05-08", "reported": "2024-05-15", "product": "Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614", "products": 1, "reason": "Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure", "recall_numbers": [ "Z-1785-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=207040" }, { "event_id": "94338", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2024-03-28", "classified": "2024-04-26", "reported": "2024-05-08", "product": "Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator", "products": 1, "reason": "inability to reprogram one device", "recall_numbers": [ "Z-1691-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206963" }, { "event_id": "94251", "slug": "abbott", "firm": "Abbott Molecular, Inc.", "class": "Class II", "initiated": "2024-03-20", "classified": "2024-04-19", "reported": "2024-05-01", "product": "Alinity m System, Part Number: 08N53-002", "products": 1, "reason": "The Alinity m System camera detects whether tubes are \"capped.\" If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar.\" Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.", "recall_numbers": [ "Z-1602-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206738" }, { "event_id": "94274", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2024-03-19", "classified": "2024-05-10", "reported": "2024-05-22", "product": "Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000", "products": 13, "reason": "Potential for unsealed sterile packing.", "recall_numbers": [ "Z-1793-2024", "Z-1794-2024", "Z-1795-2024", "Z-1796-2024", "Z-1797-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206791" }, { "event_id": "94266", "slug": "medtronic", "firm": "Covidien LP", "class": "Class II", "initiated": "2024-03-15", "classified": "2024-04-24", "reported": "2024-05-01", "product": "Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P", "products": 2, "reason": "Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating", "recall_numbers": [ "Z-1634-2024", "Z-1635-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206773" }, { "event_id": "94287", "slug": "abbvie", "firm": "Allergan Sales, LLC", "class": "Class II", "initiated": "2024-03-14", "classified": "2024-04-29", "reported": "2024-05-08", "product": "Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,", "products": 1, "reason": "Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.", "recall_numbers": [ "Z-1694-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206840" }, { "event_id": "94304", "slug": "merit-medical", "firm": "Merit Medical Systems, Inc.", "class": "Class II", "initiated": "2024-03-14", "classified": "2024-05-20", "reported": "2024-05-29", "product": "Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY", "products": 2, "reason": "Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.", "recall_numbers": [ "Z-1874-2024", "Z-1875-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206890" }, { "event_id": "94194", "slug": "stryker", "firm": "Wright Medical Technology, Inc.", "class": "Class II", "initiated": "2024-03-06", "classified": "2024-04-04", "reported": "2024-04-10", "product": "stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty", "products": 1, "reason": "Stryker has identified an issue that impacts specific lots of Infinity\" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.", "recall_numbers": [ "Z-1477-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206543" }, { "event_id": "94250", "slug": "artivion", "firm": "Artivion, Inc", "class": "Class II", "initiated": "2024-03-06", "classified": "2024-04-16", "reported": "2024-04-24", "product": "CryoValve SG Cryopreserved Pulmonary Human Heart Valve", "products": 1, "reason": "The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.", "recall_numbers": [ "Z-1545-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206737" }, { "event_id": "94162", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-03-05", "classified": "2024-03-28", "reported": "2024-04-03", "product": "OptiCross Coronary Imaging Catheter, REF H749518080120", "products": 1, "reason": "Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.", "recall_numbers": [ "Z-1396-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206479" }, { "event_id": "94205", "slug": "abbott", "firm": "Abbott GmbH", "class": "Class II", "initiated": "2024-03-04", "classified": "2024-04-04", "reported": "2024-04-10", "product": "ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35", "products": 2, "reason": "Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: \" ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). \" Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).", "recall_numbers": [ "Z-1479-2024", "Z-1480-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206562" }, { "event_id": "94190", "slug": "abbott", "firm": "Alere San Diego, Inc.", "class": "Class II", "initiated": "2024-03-01", "classified": "2024-04-30", "reported": "2024-05-08", "product": "Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170", "products": 1, "reason": "There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.", "recall_numbers": [ "Z-1702-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206539" }, { "event_id": "94131", "slug": "medtronic", "firm": "Covidien, LP", "class": "Class II", "initiated": "2024-02-28", "classified": "2024-04-03", "reported": "2024-04-10", "product": "Covidien Auto Suture\" Blunt Tip Trocar, Product Number OMS-T10BT", "products": 7, "reason": "The potential for trocar seal disengagement when using mesh products incorrectly with the device.", "recall_numbers": [ "Z-1465-2024", "Z-1466-2024", "Z-1467-2024", "Z-1468-2024", "Z-1469-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206394" }, { "event_id": "94215", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2024-02-27", "classified": "2024-04-25", "reported": "2024-05-01", "product": "TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F", "products": 12, "reason": "The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell", "recall_numbers": [ "Z-1621-2024", "Z-1622-2024", "Z-1623-2024", "Z-1624-2024", "Z-1625-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206582" }, { "event_id": "94127", "slug": "medtronic", "firm": "Covidien", "class": "Class II", "initiated": "2024-02-21", "classified": "2024-03-21", "reported": "2024-03-27", "product": "Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1", "products": 1, "reason": "Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a \"CLEAR\" display.", "recall_numbers": [ "Z-1330-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206389" }, { "event_id": "94149", "slug": "abbott", "firm": "Abbott Laboratories", "class": "Class II", "initiated": "2024-02-21", "classified": "2024-04-04", "reported": "2024-04-10", "product": "ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.", "products": 1, "reason": "The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction.", "recall_numbers": [ "Z-1476-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206461" }, { "event_id": "94041", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-02-20", "classified": "2024-03-28", "reported": "2024-04-03", "product": "Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system", "products": 1, "reason": "Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.", "recall_numbers": [ "Z-1390-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206181" }, { "event_id": "94165", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2024-02-20", "classified": "2024-04-11", "reported": "2024-04-17", "product": "EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509191", "products": 5, "reason": "Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration", "recall_numbers": [ "Z-1513-2024", "Z-1514-2024", "Z-1515-2024", "Z-1516-2024", "Z-1517-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206497" }, { "event_id": "94167", "slug": "medtronic", "firm": "Medtronic Inc.", "class": "Class II", "initiated": "2024-02-16", "classified": "2024-03-19", "reported": "2024-03-27", "product": "Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090", "products": 1, "reason": "There is a potential for sterile package breach.", "recall_numbers": [ "Z-1317-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206502" }, { "event_id": "93962", "slug": "stryker", "firm": "HeartSine Technologies Ltd", "class": "Class II", "initiated": "2024-02-14", "classified": "2024-02-15", "reported": "2024-02-21", "product": "HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10", "products": 1, "reason": "Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.", "recall_numbers": [ "Z-1141-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206009" }, { "event_id": "94128", "slug": "medtronic", "firm": "Covidien, LP", "class": "Class II", "initiated": "2024-02-14", "classified": "2024-04-01", "reported": "2024-04-10", "product": "Signia\" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT", "products": 2, "reason": "Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA\" Ultra Universal Stapler or Signia\" Stapling System.", "recall_numbers": [ "Z-1457-2024", "Z-1458-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206390" }, { "event_id": "94199", "slug": "stryker", "firm": "Stryker Communications", "class": "Class II", "initiated": "2024-02-08", "classified": "2024-04-09", "reported": "2024-04-17", "product": "Chromophare Surgical Light System , REF CH00000001", "products": 1, "reason": "Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.", "recall_numbers": [ "Z-1506-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206554" }, { "event_id": "94068", "slug": "medtronic", "firm": "Medtronic Perfusion Systems", "class": "Class II", "initiated": "2024-02-07", "classified": "2024-03-19", "reported": "2024-03-27", "product": "Medtronic DLP Vessel Cannula, Model Number REF 30000", "products": 1, "reason": "Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.", "recall_numbers": [ "Z-1316-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206241" }, { "event_id": "94026", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2024-02-06", "classified": "2024-03-06", "reported": "2024-03-13", "product": "NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM", "products": 8, "reason": "Potential packaging breaches of inner blister and outer sterile blister.", "recall_numbers": [ "Z-1259-2024", "Z-1260-2024", "Z-1261-2024", "Z-1262-2024", "Z-1263-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206151" }, { "event_id": "94072", "slug": "abbott", "firm": "Abbott Medical", "class": "Class II", "initiated": "2024-02-05", "classified": "2024-04-29", "reported": "2024-05-08", "product": "Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO", "products": 1, "reason": "Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.", "recall_numbers": [ "Z-1695-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206245" }, { "event_id": "93636", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2024-01-26", "classified": "2024-02-15", "reported": "2024-02-21", "product": "BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.", "products": 1, "reason": "Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums", "recall_numbers": [ "Z-1139-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204997" }, { "event_id": "93639", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2024-01-26", "classified": "2024-02-15", "reported": "2024-02-21", "product": "FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.", "products": 1, "reason": "Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.", "recall_numbers": [ "Z-1140-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205002" }, { "event_id": "94351", "slug": "medtronic", "firm": "Covidien, LP", "class": "Class II", "initiated": "2024-01-25", "classified": "2024-04-29", "reported": "2024-05-08", "product": "Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.", "products": 1, "reason": "One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.", "recall_numbers": [ "Z-1697-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=206993" }, { "event_id": "93922", "slug": "medtronic", "firm": "Micro Therapeutics, Inc.", "class": "Class II", "initiated": "2024-01-11", "classified": "2024-03-04", "reported": "2024-03-13", "product": "The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.", "products": 2, "reason": "European version of microcatheter were distributed within US which contain a different \"Indications for Use\".", "recall_numbers": [ "Z-1252-2024", "Z-1253-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205947" }, { "event_id": "93883", "slug": "medtronic", "firm": "Covidien", "class": "Class II", "initiated": "2024-01-09", "classified": "2024-04-30", "reported": "2024-05-08", "product": "Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC", "products": 2, "reason": "manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel", "recall_numbers": [ "Z-1731-2024", "Z-1732-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205778" }, { "event_id": "93709", "slug": "stryker", "firm": "Tornier, Inc", "class": "Class II", "initiated": "2024-01-03", "classified": "2024-01-19", "reported": "2024-01-31", "product": "Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.", "products": 1, "reason": "The incorrect device is contained in the labeled package.", "recall_numbers": [ "Z-0773-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205269" }, { "event_id": "93830", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2023-12-22", "classified": "2024-02-06", "reported": "2024-02-14", "product": "HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty", "products": 2, "reason": "Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility", "recall_numbers": [ "Z-0999-2024", "Z-1000-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205597" }, { "event_id": "93768", "slug": "medtronic", "firm": "Covidien LP", "class": "Class II", "initiated": "2023-12-21", "classified": "2024-01-29", "reported": "2024-02-07", "product": "Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT", "products": 2, "reason": "Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.", "recall_numbers": [ "Z-0844-2024", "Z-0845-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205402" }, { "event_id": "93714", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2023-12-19", "classified": "2024-01-22", "reported": "2024-01-31", "product": "Model A710 Intellis Clinician Programmer Application, version 2.0.97", "products": 1, "reason": "Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.", "recall_numbers": [ "Z-0780-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205296" }, { "event_id": "93794", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2023-12-19", "classified": "2024-02-16", "reported": "2024-02-28", "product": "EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.", "products": 1, "reason": "Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.", "recall_numbers": [ "Z-1153-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205630" }, { "event_id": "93711", "slug": "abbott", "firm": "St. Jude Medical, Atrial Fibrillation Division, Inc.", "class": "Class II", "initiated": "2023-12-18", "classified": "2024-01-25", "reported": "2024-01-31", "product": "TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.", "products": 1, "reason": "When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.", "recall_numbers": [ "Z-0814-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205276" }, { "event_id": "93592", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2023-12-14", "classified": "2024-02-06", "reported": "2024-02-14", "product": "FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)", "products": 2, "reason": "Their is a potential for false positive results when using Pneumonia panel.", "recall_numbers": [ "Z-0993-2024", "Z-0994-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204923" }, { "event_id": "93663", "slug": "medtronic", "firm": "Medtronic Inc.", "class": "Class II", "initiated": "2023-12-07", "classified": "2024-01-22", "reported": "2024-01-31", "product": "Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1", "products": 1, "reason": "During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.", "recall_numbers": [ "Z-0779-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205068" }, { "event_id": "93678", "slug": "stryker", "firm": "Stryker, Inc.", "class": "Class II", "initiated": "2023-12-06", "classified": "2024-02-14", "reported": "2024-02-21", "product": "Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm", "products": 2, "reason": "The microcatheter IFU contains an intended use that has not been evaluated by the FDA.", "recall_numbers": [ "Z-1084-2024", "Z-1085-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205097" }, { "event_id": "93687", "slug": "stryker", "firm": "Howmedica Osteonics Corp.", "class": "Class II", "initiated": "2023-12-01", "classified": "2024-01-31", "reported": "2024-02-07", "product": "Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910", "products": 58, "reason": "Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.", "recall_numbers": [ "Z-0869-2024", "Z-0870-2024", "Z-0871-2024", "Z-0872-2024", "Z-0873-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205121" }, { "event_id": "93519", "slug": "boston-scientific", "firm": "Boston Scientific Corporation", "class": "Class II", "initiated": "2023-11-30", "classified": "2024-01-05", "reported": "2024-01-17", "product": "Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus. ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra, and NEXUS I Plus.", "products": 1, "reason": "The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.", "recall_numbers": [ "Z-0673-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204639" }, { "event_id": "93611", "slug": "medtronic", "firm": "Medtronic Navigation, Inc.", "class": "Class II", "initiated": "2023-11-28", "classified": "2024-01-10", "reported": "2024-01-17", "product": "Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS", "products": 2, "reason": "Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.", "recall_numbers": [ "Z-0698-2024", "Z-0699-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204964" }, { "event_id": "93526", "slug": "biomerieux", "firm": "BioFire Diagnostics, LLC", "class": "Class II", "initiated": "2023-11-27", "classified": "2024-01-10", "reported": "2024-01-17", "product": "The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.", "products": 2, "reason": "A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.", "recall_numbers": [ "Z-0703-2024", "Z-0704-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204651" }, { "event_id": "93558", "slug": "medtronic", "firm": "Medtronic Inc.", "class": "Class II", "initiated": "2023-11-20", "classified": "2024-01-02", "reported": "2024-01-10", "product": "Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.", "products": 1, "reason": "Seal defects could compromise the ability of the product packaging to maintain sterility.", "recall_numbers": [ "Z-0623-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204795" }, { "event_id": "93561", "slug": "medtronic", "firm": "Covidien", "class": "Class II", "initiated": "2023-11-16", "classified": "2024-01-03", "reported": "2024-01-10", "product": "Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD", "products": 1, "reason": "Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable", "recall_numbers": [ "Z-0631-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204804" }, { "event_id": "93722", "slug": "medtronic", "firm": "Covidien LP", "class": "Class II", "initiated": "2023-11-16", "classified": "2024-02-06", "reported": "2024-02-14", "product": "AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30", "products": 1, "reason": "Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility", "recall_numbers": [ "Z-0986-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205313" }, { "event_id": "93675", "slug": "medtronic", "firm": "Medtronic MiniMed, Inc.", "class": "Class II", "initiated": "2023-11-15", "classified": "2024-02-07", "reported": "2024-02-14", "product": "Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3", "products": 1, "reason": "Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.", "recall_numbers": [ "Z-1005-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205092" }, { "event_id": "93481", "slug": "medtronic", "firm": "Medtronic Neuromodulation", "class": "Class II", "initiated": "2023-11-13", "classified": "2023-12-22", "reported": "2024-01-03", "product": "Medtronic SynchroMed II, Model 8637-20, Programmable pump", "products": 2, "reason": "Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.", "recall_numbers": [ "Z-0614-2024", "Z-0615-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204479" }, { "event_id": "98483", "slug": "stryker", "firm": "HeartSine Technologies Ltd", "class": "Class III", "initiated": "2026-07-27", "classified": "2026-09-25", "reported": "2026-10-07", "product": "HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069", "products": 1, "reason": "Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.", "recall_numbers": [ "Z-3270-2026" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218886" }, { "event_id": "95557", "slug": "abbott", "firm": "Abbott Medical", "class": "Class III", "initiated": "2024-10-01", "classified": "2024-11-26", "reported": "2024-12-04", "product": "Merlin@home Transmitter REF EX1100 The Merlin@home\" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net\" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.", "products": 2, "reason": "Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.", "recall_numbers": [ "Z-0551-2025", "Z-0552-2025" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210582" }, { "event_id": "93902", "slug": "abbott", "firm": "Abbott Molecular, Inc.", "class": "Class III", "initiated": "2024-02-01", "classified": "2024-02-26", "reported": "2024-03-06", "product": "Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)", "products": 3, "reason": "Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.", "recall_numbers": [ "Z-1188-2024", "Z-1189-2024", "Z-1190-2024" ], "link": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=205838" } ] }