Stryker
SYK NYSE
Medicare add-on payments
- New
- 0
- Continued
- 2
- Lost
- 0
| Status | Technology | Max add-on payment | Implied cost per case |
|---|---|---|---|
| Continued | 4WEB Medical Ankle Truss System | $15,275 | $23,500 |
| Continued | LimFlow System | $16,250 | $25,000 |
FDA device recalls, last 36 months
FDA data as of . Source: openFDA. FDA data may be out of date.
| Class | Product | Reason | Initiated | FDA record |
|---|---|---|---|---|
| Class I | 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 II | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | BARD Dynamic Tip Steerable, Product Number 6DYNTP001;+25 more products | Incomplete seals on sterile product | Apr 10, 2026 | FDA record |
| Class II | 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 | 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 | 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 | 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 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 | Cub Pediatric Crib, Model FL19H | Cribs sold in the USA are missing two access door warning labels. | Feb 18, 2026 | FDA record |
| Class II | 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 | 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 | 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 | 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 | 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 | Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23 | Incorrect expiration date | Dec 5, 2025 | FDA record |
| Class II | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |