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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
May 12, 2020 Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Par... The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... Class II Covidien Llc
May 12, 2020 Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usag... Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. T... Class II Med Tec Inc
May 12, 2020 Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Par... The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... Class II Covidien Llc
May 12, 2020 Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for c... Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) Class I Medtronic Vascular Galway DBA Medtronic Ireland
May 12, 2020 MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous... Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... Class II DiaSorin Molecular LLC
May 12, 2020 Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Pro... The product is recalled due to a manufacturing assembly error that may cause the staples to fail ... Class II Covidien Llc
May 12, 2020 MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the ... Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occ... Class II DiaSorin Molecular LLC
May 11, 2020 ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Pr... Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ... Class II Radiometer Medical ApS
May 11, 2020 ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 0570069393841... Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, ... Class II Radiometer Medical ApS
May 11, 2020 VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI #... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Produc... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01... The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS... Class II Biomet, Inc.
May 11, 2020 VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # ... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 8, 2020 uCT 530 Computed Tomography X-Ray System Two issues were identified with the computed tomography x-ray system including a service function... Class II Shanghai United Imaging Healthcare Co., Ltd.
May 8, 2020 Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Produc... Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. Class II Arrow International Inc
May 8, 2020 uCT 760 System, Computed Tomography X-ray System Two issues were identified with the computed tomography x-ray system including an intermittent i... Class II Shanghai United Imaging Healthcare Co., Ltd.
May 8, 2020 Merge Healthcare Merge Application Server Software Release and Merge Healthca... An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score c... Class II Merge Healthcare, Inc.
May 8, 2020 The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images o... GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referr... Class II Ge Healthcare
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Pro... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00... Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample ... Class II Siemens Healthcare Diagnostics, Inc.
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - P... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be us... If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum b... Class II Siemens Medical Solutions USA, Inc
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: ... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage:... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00... Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample ... Class II Siemens Healthcare Diagnostics, Inc.
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 7, 2020 Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Pr... Seal integrity of the blister pack may be compromised and sterility cannot be assured Class II Stryker GmbH
May 6, 2020 Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-A... A material weakness adjacent to the polymer fill channel may become compromised during pressuriza... Class I Endologix, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Num... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number ... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Num... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within... Products repaired with the incorrect service manual may be missing an O ring and are subject to r... Class II Olympus Corporation of the Americas
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Num... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.