Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

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DateProductReasonClassFirm
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 T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single pat... Reports that the T-piece does not fit on the nebulizer. Class II Salter Labs
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 Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. I... Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product ... Class II Bard Peripheral Vascular Inc
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 InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, S... Potential for the female luer component of the InVision-Plus IV connector to crack during use. Class II Rymed Technologies, LLC
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 Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. I... Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm ... Class II Bard Peripheral Vascular Inc
Jan 5, 2016 InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposabl... Potential for the female luer component of the InVision-Plus IV connector to crack during use. Class II Rymed Technologies, LLC
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.
Jan 4, 2016 Philips IntelliVue Module Measurement X2 Model: M3002A The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound ... Class II Philips Electronics North America Corporation
Jan 4, 2016 Philips IntelliVue Measurement Module X1 Model: M3001A The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound ... Class II Philips Electronics North America Corporation
Jan 4, 2016 REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapte... Report by a customer of an open package seal. Class III C.R. Bard, Inc.
Jan 4, 2016 Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. ... Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced betw... Class II Otto Bock Healthcare GmbH

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.