FDA device recalls, by public company
Every matched FDA device recall for the companies MediDash tracks, most serious first. Updated weekly from FDA data.
FDA data as of . Source: openFDA. FDA data may be out of date.
Recalls
Showing 44 Class I of 372 recalls.
| Class | Company | Product | Reason | Initiated | FDA record |
|---|---|---|---|---|---|
| Class I | Boston Scientific BSX NYSE | 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;… | 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. | Aug 24, 2026 | FDA record |
| Class I | Medtronic MDT NYSE | 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… | 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,… | Aug 6, 2026 | FDA record |
| Class I | Boston Scientific BSX NYSE | Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter+1 more products | Potential for arterial sheath tip separation or partial tip separation during use. | Jul 9, 2026 | FDA record |
| Class I | Boston Scientific BSX NYSE | INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part… | 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… | Jun 17, 2026 | FDA record |
| Class I | Medtronic MDT NYSE | Medtronic Harmony Delivery Catheter System | 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. | May 22, 2026 | FDA record |
| Class I | Boston Scientific BSX NYSE | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number…+1 more products | 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… | Mar 19, 2026 | FDA record |
| Class I | Merit Medical MMSI NASDAQ | CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D,…+4 more products | 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… | Feb 13, 2026 | FDA record |
| Class I | Boston Scientific BSX NYSE | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;+5 more products | 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… | Dec 19, 2025 | FDA record |
| Class I | Abbott ABT NYSE | 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…+3 more products | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | Nov 24, 2025 | FDA record |
| Class I | Stryker SYK NYSE | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only | Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. | Oct 13, 2025 | FDA record |
| Class I | Abbott ABT NYSE | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter+4 more products | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. | Sep 10, 2025 | FDA record |
| Class I | Boston Scientific BSX NYSE | Model Number L211 PROPONENT DR SL MRI Pacemaker+26 more products | 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,… | Aug 20, 2025 | FDA record |
| Class I | Medtronic MDT NYSE | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110+2 more products | The catheters may not retain their shape. | Aug 6, 2025 | FDA record |
| Class I | Boston Scientific BSX NYSE | WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left…+10 more products | 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… | Jul 29, 2025 | FDA record |
| Class I | Boston Scientific BSX NYSE | ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286,…+2 more products | 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… | Jul 24, 2025 | FDA record |
| Class I | Boston Scientific BSX NYSE | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID… | 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… | Jul 7, 2025 | FDA record |
| Class I | Abbott ABT NYSE | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The…+1 more products | 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. | Jun 23, 2025 | FDA record |
| Class I | Medtronic MDT NYSE | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance,… | 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… | Jun 3, 2025 | FDA record |
| Class I | Medtronic MDT NYSE | 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 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… | May 21, 2025 | FDA record |
| Class I | Edwards Lifesciences EW NYSE | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description:…+5 more products | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. | May 14, 2025 | FDA record |
| Class I | Abbott ABT NYSE | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left… | 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… | Mar 13, 2025 | FDA record |
| Class I | Medtronic MDT NYSE | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R | 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… | Feb 26, 2025 | FDA record |
| Class I | Medtronic MDT NYSE | 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.… | 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… | Feb 5, 2025 | FDA record |
| Class I | Medtronic MDT NYSE | 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,…+1 more products | 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… | Jan 30, 2025 | FDA record |
| Class I | Boston Scientific BSX NYSE | 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…+5 more products | 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… | Dec 12, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | 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…+1 more products | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). | Nov 1, 2024 | FDA record |
| Class I | Boston Scientific BSX NYSE | Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100+6 more products | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. | Oct 10, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | 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;…+2 more products | 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… | Jul 31, 2024 | FDA record |
| Class I | Abbott ABT NYSE | FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System | 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… | Jul 24, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only+1 more products | Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. | Jul 9, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01,… | 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… | Jun 24, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | 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… | Potential for false negative response on the NIM Vital Nerve Monitoring System | Jun 24, 2024 | FDA record |
| Class I | Abbott ABT NYSE | Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left… | 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… | May 8, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical… | 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. | Mar 26, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. | Mar 25, 2024 | FDA record |
| Class I | Boston Scientific BSX NYSE | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter+47 more products | 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… | Mar 21, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.+2 more products | The failure to detect the partial obstruction in a 2.5mm sensor. | Mar 21, 2024 | FDA record |
| Class I | bioMérieux BIM EPA | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c)… | 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. | Mar 14, 2024 | FDA record |
| Class I | Abbott ABT NYSE | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly+1 more products | Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. | Mar 1, 2024 | FDA record |
| Class I | Boston Scientific BSX NYSE | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 | 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… | Feb 20, 2024 | FDA record |
| Class I | Abbott ABT NYSE | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2.…+1 more products | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. | Feb 19, 2024 | FDA record |
| Class I | Boston Scientific BSX NYSE | Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 | 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… | Feb 12, 2024 | FDA record |
| Class I | Medtronic MDT NYSE | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid…+4 more products | Potential for catheter disconnection from the patient line stopcock connectors. | Jan 22, 2024 | FDA record |
| Class I | Abbott ABT NYSE | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication… | Due to software and controller systems that results in unexpected pump start or pump stop. | Jan 3, 2024 | FDA record |
| Class II | Stryker SYK NYSE | REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM+5 more products | Reusable access port system may crack or seperate during use. | Aug 19, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | 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)+2 more products | 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… | Aug 6, 2026 | FDA record |
| Class II | Stryker SYK NYSE | 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…+11 more products | 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… | Jul 30, 2026 | FDA record |
| Class II | Stryker SYK NYSE | 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… | Due to a damaged (over stretched) membrane tail that causes an intermittent fault. | Jul 27, 2026 | FDA record |
| Class II | bioMérieux BIM EPA | VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 | 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… | Jul 24, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1)… | 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. | Jul 22, 2026 | FDA record |
| Class II | bioMérieux BIM EPA | FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed,… | 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. | Jul 16, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.+1 more products | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Jul 14, 2026 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.+6 more products | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Jul 1, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | 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:…+2 more products | Potential for breach in sterile barrier of device packaging. | Jun 30, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | Rapid Refill Continuous Injection System, UPN M00566001 | 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… | Jun 30, 2026 | FDA record |
| Class II | bioMérieux BIM EPA | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic | Due to increase in false negative results | Jun 24, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722+5 more products | 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. | Jun 24, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX…+4 more products | 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. | Jun 24, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System. | 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… | Jun 19, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Ventriculostomy Kit, REF: 46154 | 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… | Jun 17, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter+2 more products | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. | Jun 11, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter | Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. | Jun 11, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU…+3 more products | 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… | Jun 11, 2026 | FDA record |
| Class II | Roche ROP SIX | Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx. | Software issue that can cause an increase in spontaneous software closures. | Jun 10, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter+1 more products | 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. | Jun 8, 2026 | FDA record |
| Class II | Stryker SYK NYSE | STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640+4 more products | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Jun 8, 2026 | FDA record |
| Class II | bioMérieux BIM EPA | VITEK 2 AST-N447 TEST KIT Product reference 424620 | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. | Jun 4, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula+1 more products | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | May 25, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | CRE Pro Wireguided 12-15mm 240cm+11 more products | Potential sterile breach of the pouches in which devices are packaged. | May 21, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic O-arm O2 Imaging System. Model Number: BI70002000. | Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. | May 19, 2026 | FDA record |
| Class II | Stryker SYK NYSE | TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.+1 more products | 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… | May 19, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor+1 more products | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | May 13, 2026 | FDA record |
| Class II | Abbott ABT NYSE | Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The…+2 more products | Due to 11 volt Backup Battery failures. | May 13, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096… | The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. | May 13, 2026 | FDA record |
| Class II | Abbott ABT NYSE | Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software | Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. | May 12, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Octopus Evolution AS Tissue Stabilizer, Model TS2500+2 more products | 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… | May 12, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | 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… | 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. | May 12, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. | May 11, 2026 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes:… | Due to unsealed portions of pouches. | May 8, 2026 | FDA record |
| Class II | Stryker SYK NYSE | Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System | 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… | May 6, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | 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…+1 more products | Reusable electrodes may not meet expected performance levels. | Apr 29, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 | Sterile anchors my lack sterility assurance. | Apr 29, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable… | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. | Apr 23, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050+2 more products | Temperature probe devices lack FDA clearance. | Apr 23, 2026 | FDA record |
| Class II | bioMérieux BIM EPA | BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | Contamination to in-vitro diagnostic test may result in false positives. | Apr 22, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU,… | 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. | Apr 22, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter+8 more products | Certain lots of product have the potential for a sterile barrier breach. | Apr 21, 2026 | FDA record |
| Class II | Roche ROP SIX | navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code:… | Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window | Apr 20, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing… | Due to customer complaint regarding incorrect display box labeling. | Apr 15, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071; | 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. | Apr 15, 2026 | FDA record |
| Class II | Stryker SYK NYSE | LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number:… | 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… | Apr 13, 2026 | FDA record |
| Class II | Stryker SYK NYSE | LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935,… | 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… | Apr 13, 2026 | FDA record |
| Class II | Stryker SYK NYSE | BARD Dynamic Tip Steerable, Product Number 6DYNTP001;+25 more products | Incomplete seals on sterile product | Apr 10, 2026 | FDA record |
| Class II | Stryker SYK NYSE | Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart… | Due to nonconforming products being inadvertently distributed. | Apr 9, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN… | 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… | Apr 8, 2026 | FDA record |
| Class II | Stryker SYK NYSE | INZONE DETACHMENT SYSTEM, REF: M00345100950 | 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… | Apr 6, 2026 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY+2 more products | catheter may experience resistance when being advanced over the guidewire | Apr 2, 2026 | FDA record |
| Class II | Abbott ABT NYSE | i-STAT G3+ cartridge; List Number: 03P78-26;+2 more products | 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… | Apr 1, 2026 | FDA record |
| Class II | bioMérieux BIM EPA | Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 | Respiratory/sore throat panel test may result in false negative results and control failures. | Apr 1, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5+1 more products | 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… | Mar 30, 2026 | FDA record |
| Class II | Edwards Lifesciences EW NYSE | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. | Mar 27, 2026 | FDA record |
| Class II | Roche ROP SIX | Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park… | Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. | Mar 24, 2026 | FDA record |
| Class II | Roche ROP SIX | Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants | Mar 20, 2026 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color… | 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. | Mar 12, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter. | 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… | Mar 11, 2026 | FDA record |
| Class II | Stryker SYK NYSE | 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,… | 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. | Mar 5, 2026 | FDA record |
| Class II | Stryker SYK NYSE | Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 | Surgical light assembly may not adequate support the weight of the ceiling cover. | Feb 23, 2026 | FDA record |
| Class II | Stryker SYK NYSE | Cub Pediatric Crib, Model FL19H | Cribs sold in the USA are missing two access door warning labels. | Feb 18, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)+13 more products | 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,… | Feb 13, 2026 | FDA record |
| Class II | Stryker SYK NYSE | TMJ Bilateral Implants, REF: CHG020 | 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. | Feb 11, 2026 | FDA record |
| Class II | Boston Scientific BSX NYSE | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; | 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… | Feb 10, 2026 | FDA record |
| Class II | Abbott ABT NYSE | Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus… | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. | Feb 9, 2026 | FDA record |
| Class II | Stryker SYK NYSE | MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 | 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… | Feb 2, 2026 | FDA record |
| Class II | Artivion AORT NYSE | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 | Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. | Feb 1, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital… | 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. | Jan 30, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 | 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… | Jan 30, 2026 | FDA record |
| Class II | Otsuka Holdings 4578 TSE | Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description:…+1 more products | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | Jan 29, 2026 | FDA record |
| Class II | Stryker SYK NYSE | PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number:… | Due to pediatric defibrillator electrode delamination | Jan 21, 2026 | FDA record |
| Class II | Stryker SYK NYSE | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) -… | 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. | Jan 21, 2026 | FDA record |
| Class II | Roche ROP SIX | cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material… | 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… | Jan 20, 2026 | FDA record |
| Class II | Medtronic MDT NYSE | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 | 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… | Jan 13, 2026 | FDA record |
| Class II | bioMérieux BIM EPA | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o… | 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… | Jan 5, 2026 | FDA record |
| Class II | Stryker SYK NYSE | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 | 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… | Dec 19, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Mazor X robotic guidance system REF: TPL0059 | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. | Dec 10, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23 | Incorrect expiration date | Dec 5, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.+1 more products | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Dec 4, 2025 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Allwell Inflation Device, for angiographic use REF: IS-30-A+6 more products | Inflation device handle may detach from the syringe during procedure. | Dec 4, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090… | 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. | Dec 4, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on… | Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. | Dec 3, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | 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… | 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… | Dec 3, 2025 | FDA record |
| Class II | Roche ROP SIX | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence… | 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. | Nov 21, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B… | 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… | Nov 20, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | InPen App, Model/CFN Number: MMT-8061 (Android Users) | 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… | Nov 13, 2025 | FDA record |
| Class II | Abbott ABT NYSE | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | 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… | Nov 13, 2025 | FDA record |
| Class II | Stryker SYK NYSE | The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting… | 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. | Nov 12, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | 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… | 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. | Nov 2, 2025 | FDA record |
| Class II | Stryker SYK NYSE | NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026…+2 more products | Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. | Oct 31, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Arise 1000EX mattress, Part Number 2236000000+1 more products | 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… | Oct 31, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 | There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. | Oct 29, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174+1 more products | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. | Oct 29, 2025 | FDA record |
| Class II | bioMérieux BIM EPA | BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) | Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. | Oct 22, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | CareLink Clinic, REF: MMT-7350 | 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… | Oct 21, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | 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. | Oct 20, 2025 | FDA record |
| Class II | Abbott ABT NYSE | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00;… | 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… | Oct 10, 2025 | FDA record |
| Class II | Abbott ABT NYSE | Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT,…+3 more products | Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. | Oct 9, 2025 | FDA record |
| Class II | Abbott ABT NYSE | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400+1 more products | 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… | Oct 6, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | 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… | Oct 3, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;+1 more products | 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. | Sep 25, 2025 | FDA record |
| Class II | Stryker SYK NYSE | HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY | Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. | Sep 24, 2025 | FDA record |
| Class II | Stryker SYK NYSE | 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 | Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. | Sep 18, 2025 | FDA record |
| Class II | Abbott ABT NYSE | 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… | 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. | Sep 18, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model… | 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… | Sep 16, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. | Sep 12, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | TENACIO Pump without InhibiZone; UPN: 72404420;+6 more products | The potential for devices to experience inflation and/or deflation performance issues or difficulties. | Sep 11, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above); | 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. | Aug 28, 2025 | FDA record |
| Class II | Stryker SYK NYSE | 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; | 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. | Aug 28, 2025 | FDA record |
| Class II | Abbott ABT NYSE | i-STAT CG4+ cartridge (white). List Number: 03P85-25. | 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. | Aug 21, 2025 | FDA record |
| Class II | Abbott ABT NYSE | i-STAT EG6+ cartridge. List Number: 03P77-25.+2 more products | 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. | Aug 21, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000+1 more products | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | Aug 18, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)+3 more products | 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… | Aug 5, 2025 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | 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,… | 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. | Aug 4, 2025 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore… | 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. | Jul 25, 2025 | FDA record |
| Class II | Stryker SYK NYSE | LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for…+2 more products | Due to required inspections not being performed on products/units that have gone through servicing. | Jul 22, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving… | Due to out of the box wobble of the driver. | Jul 17, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034 | Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. | Jul 15, 2025 | FDA record |
| Class II | bioMérieux BIM EPA | FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the… | 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. | Jul 10, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the… | 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… | Jul 8, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 | 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… | Jul 8, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235;… | 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… | Jul 2, 2025 | FDA record |
| Class II | Stryker SYK NYSE | HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator) | Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) | Jun 30, 2025 | FDA record |
| Class II | bioMérieux BIM EPA | VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments,… | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards | Jun 26, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 | The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end. | Jun 25, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J,… | 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… | Jun 23, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip+1 more products | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. | Jun 18, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software…+1 more products | 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… | Jun 18, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra…+1 more products | 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… | Jun 17, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) | 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… | Jun 16, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | 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…+3 more products | 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… | Jun 10, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF… | 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. | Jun 6, 2025 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548,…+3 more products | 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. | Jun 5, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. | May 28, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | O-arm O2 Imaging System. Mobile X-Ray System. | A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. | May 27, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.+1 more products | 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. | May 22, 2025 | FDA record |
| Class II | Stryker SYK NYSE | 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… | Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use. | May 21, 2025 | FDA record |
| Class II | Abbott ABT NYSE | 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… | 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… | May 21, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic, Simplera Sensor, REF: MMT-5100JD1 | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection. | May 7, 2025 | FDA record |
| Class II | bioMérieux BIM EPA | BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems | Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. | Apr 30, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Azure S DR MRI SureScan, Product number W3DR01 | 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… | Apr 29, 2025 | FDA record |
| Class II | Abbott ABT NYSE | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended…+1 more products | There were reports of an increase in reactive negative controls and false positive results. | Apr 28, 2025 | FDA record |
| Class II | Roche ROP SIX | FoundationOne Companion Diagnostic (F1CDx) | 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… | Apr 9, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Artix MT Thrombectomy Device, REF: 32-102 | 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… | Apr 8, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Enhanced Verify Evaluation Handset (CFN HH90130FA) | 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… | Apr 3, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;+1 more products | 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. | Mar 28, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | 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…+3 more products | 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… | Mar 24, 2025 | FDA record |
| Class II | Abbott ABT NYSE | 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… | 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… | Mar 20, 2025 | FDA record |
| Class II | Abbott ABT NYSE | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description:…+4 more products | 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… | Mar 18, 2025 | FDA record |
| Class II | Abbott ABT NYSE | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080+1 more products | 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… | Mar 17, 2025 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly+1 more products | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. | Mar 14, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT… | 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. | Mar 10, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA | 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.… | Mar 4, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118)… | There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. | Mar 4, 2025 | FDA record |
| Class II | Abbott ABT NYSE | 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…+2 more products | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Mar 4, 2025 | FDA record |
| Class II | Abbott ABT NYSE | 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…+2 more products | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Mar 4, 2025 | FDA record |
| Class II | Stryker SYK NYSE | stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented | 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… | Mar 3, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.+3 more products | Potential for the gold unlock button to separate from the inserter. | Feb 28, 2025 | FDA record |
| Class II | bioMérieux BIM EPA | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 | Increased risk of control failures and false negative test results with multiplexed nucleic acid test. | Feb 27, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL+13 more products | 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. | Feb 25, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 -…+9 more products | 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.… | Feb 17, 2025 | FDA record |
| Class II | Abbott ABT NYSE | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir… | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. | Feb 15, 2025 | FDA record |
| Class II | Stryker SYK NYSE | LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest. | Incorrect keypad was incorrectly installed onto a defibrillator/monitor. | Feb 3, 2025 | FDA record |
| Class II | Abbott ABT NYSE | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000… | 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… | Feb 3, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)+11 more products | 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.… | Jan 31, 2025 | FDA record |
| Class II | Stryker SYK NYSE | Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197 | Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment. | Jan 29, 2025 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D | Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. | Jan 27, 2025 | FDA record |
| Class II | Stryker SYK NYSE | LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II… | Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system. | Jan 21, 2025 | FDA record |
| Class II | Stryker SYK NYSE | LIFEPAK 35 ECG cable REF 11111-000041 | Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions | Jan 21, 2025 | FDA record |
| Class II | Medtronic MDT NYSE | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. | Jan 9, 2025 | FDA record |
| Class II | Stryker SYK NYSE | stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades+1 more products | Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. | Jan 8, 2025 | FDA record |
| Class II | Boston Scientific BSX NYSE | AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740+13 more products | 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. | Dec 20, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)+2 more products | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Dec 12, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference… | Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. | Dec 4, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 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… | 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… | Dec 3, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within… | 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:… | Dec 3, 2024 | FDA record |
| Class II | Abbott ABT NYSE | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the… | 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… | Nov 21, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version…+3 more products | Software issues were identified in application version 2.x. | Nov 21, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100)… | Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings. | Nov 6, 2024 | FDA record |
| Class II | Abbott ABT NYSE | 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.+3 more products | 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. | Nov 6, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | AMS Artificial Urinary Sphincter Control Pump+1 more products | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) | Oct 28, 2024 | FDA record |
| Class II | Roche ROP SIX | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine | Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias) | Oct 17, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile+4 more products | 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… | Oct 17, 2024 | FDA record |
| Class II | Abbott ABT NYSE | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN)…+1 more products | 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. | Oct 5, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including cutting and…+5 more products | 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… | Oct 4, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery | There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal | Oct 3, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. | 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. | Sep 24, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | 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… | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. | Sep 19, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable… | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. | Sep 18, 2024 | FDA record |
| Class II | Abbott ABT NYSE | 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+1 more products | 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… | Sep 12, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption in the pump memory. | Sep 11, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application. | 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. | Sep 6, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to…+21 more products | 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… | Sep 5, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in… | 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… | Sep 5, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision… | 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. | Sep 4, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 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… | 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. | Aug 30, 2024 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to…+5 more products | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Aug 30, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 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… | Due to an out of tolerance tool being used on monitor/defibrillator systems. | Aug 30, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty | 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. | Aug 29, 2024 | FDA record |
| Class II | Stryker SYK NYSE | stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). | Aug 29, 2024 | FDA record |
| Class II | Stryker SYK NYSE | AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in… | 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. | Aug 23, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an… | 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… | Aug 22, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Vanta Implantable Neurostimulator (INS), Model 977006 | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements. | Aug 21, 2024 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C+9 more products | 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. | Aug 19, 2024 | FDA record |
| Class II | Roche ROP SIX | 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)… | 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. | Aug 15, 2024 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Custom Procedure Kit, REF: K12T-11077+1 more products | 7F sheath introducers labeled as 7.5F | Aug 12, 2024 | FDA record |
| Class II | Stryker SYK NYSE | STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the… | 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. | Aug 9, 2024 | FDA record |
| Class II | bioMérieux BIM EPA | FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W+1 more products | 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… | Aug 7, 2024 | FDA record |
| Class II | Stryker SYK NYSE | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. | Aug 7, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. | Aug 5, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining…+30 more products | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | Aug 1, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping,…+9 more products | 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… | Jul 24, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF,… | Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO | Jul 24, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.+4 more products | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. | Jul 18, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 | 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… | Jul 17, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument | 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. | Jul 17, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product… | 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. | Jul 11, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | IFU update to address device's battery handling information. | Jul 9, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 | 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). | Jul 9, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Product was distributed past expiration date. | Jul 5, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A | 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… | Jul 2, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are…+1 more products | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention. | Jun 27, 2024 | FDA record |
| Class II | Roche ROP SIX | Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD | Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. | Jun 27, 2024 | FDA record |
| Class II | Abbott ABT NYSE | HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed… | 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… | Jun 25, 2024 | FDA record |
| Class II | Stryker SYK NYSE | UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043+2 more products | 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) | Jun 19, 2024 | FDA record |
| Class II | bioMérieux BIM EPA | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles:… | 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… | Jun 19, 2024 | FDA record |
| Class II | Roche ROP SIX | FoundationOne Companion Diagnostic (F1CDx) | 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. | Jun 18, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. | 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. | Jun 17, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90… | A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. | Jun 17, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Alinity hq Analyzer, REF: 09P68-01 | 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… | Jun 14, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct. | 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. | Jun 12, 2024 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management…+22 more products | 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. | Jun 11, 2024 | FDA record |
| Class II | bioMérieux BIM EPA | BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143+1 more products | 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. | Jun 10, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 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…+2 more products | Expired Products distributed to customers | Jun 3, 2024 | FDA record |
| Class II | Stryker SYK NYSE | REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly | Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. | May 31, 2024 | FDA record |
| Class II | Artivion AORT NYSE | (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with…+1 more products | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. | May 28, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910+1 more products | 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… | May 23, 2024 | FDA record |
| Class II | Abbott ABT NYSE | 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… | 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,… | May 22, 2024 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP… | 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… | May 22, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only+3 more products | 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. | May 22, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY | 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… | May 16, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only+11 more products | 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. | May 16, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | TourniKwik Tourniquet Set (CFN 79012) | Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. | May 16, 2024 | FDA record |
| Class II | bioMérieux BIM EPA | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit… | Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. | May 16, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | 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… | Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. | May 15, 2024 | FDA record |
| Class II | Roche ROP SIX | 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… | 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… | May 13, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115… | Diagnostic electrophysiology (EP) catheters do not meet testing requirements. | May 10, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit) | 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… | May 10, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System. | The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. | May 9, 2024 | FDA record |
| Class II | Abbott ABT NYSE | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 | One lot of product has dilators that are too short and will not extend outside the introducer sheath. | Apr 30, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000 | 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… | Apr 26, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only | Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms. | Apr 25, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Trevo ProVue, Catalog: 90184+7 more products | 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… | Apr 23, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320 | 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… | Apr 18, 2024 | FDA record |
| Class II | Stryker SYK NYSE | The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside…+2 more products | 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… | Apr 18, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator+22 more products | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. | Apr 16, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 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…+5 more products | 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… | Apr 15, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection… | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery | Apr 15, 2024 | FDA record |
| Class II | Stryker SYK NYSE | HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P | 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… | Apr 8, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 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… | 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. | Apr 4, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 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… | 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. | Apr 3, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial… | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure | Mar 29, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | Mar 28, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Alinity m System, Part Number: 08N53-002 | 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… | Mar 20, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | 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+12 more products | Potential for unsealed sterile packing. | Mar 19, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | 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…+1 more products | 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 | Mar 15, 2024 | FDA record |
| Class II | AbbVie ABBV NYSE | Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, | Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure. | Mar 14, 2024 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY+1 more products | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Mar 14, 2024 | FDA record |
| Class II | Stryker SYK NYSE | stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty | 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… | Mar 6, 2024 | FDA record |
| Class II | Artivion AORT NYSE | CryoValve SG Cryopreserved Pulmonary Human Heart Valve | The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. | Mar 6, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | OptiCross Coronary Imaging Catheter, REF H749518080120 | Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness. | Mar 5, 2024 | FDA record |
| Class II | Abbott ABT NYSE | ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35+1 more products | 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… | Mar 4, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | 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… | Mar 1, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT+6 more products | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Feb 28, 2024 | FDA record |
| Class II | Stryker SYK NYSE | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F+11 more products | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell | Feb 27, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 | 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… | Feb 21, 2024 | FDA record |
| Class II | Abbott ABT NYSE | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | 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… | Feb 21, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system | 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. | Feb 20, 2024 | FDA record |
| Class II | Boston Scientific BSX NYSE | 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…+4 more products | 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… | Feb 20, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090 | There is a potential for sterile package breach. | Feb 16, 2024 | FDA record |
| Class II | Stryker SYK NYSE | 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,… | 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… | Feb 14, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT+1 more products | 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… | Feb 14, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Chromophare Surgical Light System , REF CH00000001 | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. | Feb 8, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic DLP Vessel Cannula, Model Number REF 30000 | 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. | Feb 7, 2024 | FDA record |
| Class II | Stryker SYK NYSE | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM+7 more products | Potential packaging breaches of inner blister and outer sterile blister. | Feb 6, 2024 | FDA record |
| Class II | Abbott ABT NYSE | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO | Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. | Feb 5, 2024 | FDA record |
| Class II | bioMérieux BIM EPA | BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus… | Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums | Jan 26, 2024 | FDA record |
| Class II | bioMérieux BIM EPA | FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic… | Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. | Jan 26, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use… | 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,… | Jan 25, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid…+1 more products | European version of microcatheter were distributed within US which contain a different "Indications for Use". | Jan 11, 2024 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC+1 more products | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | Jan 9, 2024 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile. | The incorrect device is contained in the labeled package. | Jan 3, 2024 | FDA record |
| Class II | Stryker SYK NYSE | HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty+1 more products | 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 | Dec 22, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK…+1 more products | 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… | Dec 21, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Model A710 Intellis Clinician Programmer Application, version 2.0.97 | 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… | Dec 19, 2023 | FDA record |
| Class II | Boston Scientific BSX NYSE | EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. | 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… | Dec 19, 2023 | FDA record |
| Class II | Abbott ABT NYSE | TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile. | 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… | Dec 18, 2023 | FDA record |
| Class II | bioMérieux BIM EPA | FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)+1 more products | Their is a potential for false positive results when using Pneumonia panel. | Dec 14, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 | 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… | Dec 7, 2023 | FDA record |
| Class II | Stryker SYK NYSE | Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm+1 more products | The microcatheter IFU contains an intended use that has not been evaluated by the FDA. | Dec 6, 2023 | FDA record |
| Class II | Stryker SYK NYSE | Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910+57 more products | 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. | Dec 1, 2023 | FDA record |
| Class II | Boston Scientific BSX NYSE | Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the… | 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. | Nov 30, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS+1 more products | 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. | Nov 28, 2023 | FDA record |
| Class II | bioMérieux BIM EPA | 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…+1 more products | 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… | Nov 27, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile. | Seal defects could compromise the ability of the product packaging to maintain sterility. | Nov 20, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD | Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable | Nov 16, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally… | 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 | Nov 16, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2,… | 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… | Nov 15, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic SynchroMed II, Model 8637-20, Programmable pump+1 more products | 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… | Nov 13, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736,… | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, | Nov 7, 2023 | FDA record |
| Class II | Stryker SYK NYSE | AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 | AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA. | Nov 6, 2023 | FDA record |
| Class II | Merit Medical MMSI NASDAQ | Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B,…+2 more products | The sterility of microcatheter and infusion system devices cannot be guaranteed. | Nov 6, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor | It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device… | Nov 3, 2023 | FDA record |
| Class II | Stryker SYK NYSE | LITe Decompression Snake Arm, REF 48080230 | Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft. | Nov 1, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103+8 more products | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting… | Oct 31, 2023 | FDA record |
| Class II | Abbott ABT NYSE | Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase… | Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit. | Oct 30, 2023 | FDA record |
| Class II | Stryker SYK NYSE | stryker Sage PrimaFit External Urine Management System for the Female Anatomy | A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label | Oct 23, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators | Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. | Oct 19, 2023 | FDA record |
| Class II | Abbott ABT NYSE | Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter,… | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | Oct 19, 2023 | FDA record |
| Class II | Abbott ABT NYSE | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous…+2 more products | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | Oct 19, 2023 | FDA record |
| Class II | bioMérieux BIM EPA | FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The… | Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the… | Oct 17, 2023 | FDA record |
| Class II | bioMérieux BIM EPA | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2… | Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some… | Oct 17, 2023 | FDA record |
| Class II | Medtronic MDT NYSE | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6+2 more products | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal… | Oct 12, 2023 | FDA record |
| Class III | Abbott ABT NYSE | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device…+1 more products | 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. | Oct 1, 2024 | FDA record |
| Class III | Abbott ABT NYSE | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)+2 more products | 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. | Feb 1, 2024 | FDA record |
Methods
Class I is the most serious: the FDA judges there is a reasonable chance the product could cause serious harm or death. A recall is not always a removal. Many are corrections, such as a software fix or a label change, and the product stays in use. Recalls are matched to companies by the firm name on the FDA record, and only verified matches are shown. Recalls appear here after the FDA classifies them, usually one to two months after they begin.