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Browse Device Recalls

26 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 26 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 26 FDA device recalls.

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DateProductReasonClassFirm
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Inst... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Pro... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usag... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Produc... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Produ... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instrum... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford P... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Us... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Produc... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usag... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usag... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments f... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Pro... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Produ... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usa... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Jan 5, 2016 Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usag... Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... Class II Biomet U.K., Ltd.
Mar 20, 2013 REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found i... Investigation of complaints found excessive use of the instrument could result in cracking on the... Class II Biomet U.K., Ltd.
Jul 27, 2012 Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate che... A drafting error during an unrelated design change has led to 4 misleading dimensions on the draw... Class II Biomet U.K., Ltd.

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.