Browse Device Recalls

1,515 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,515 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 1,515 FDA device recalls.

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DateProductReasonClassFirm
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.
Dec 9, 2015 Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight ... The product on the package label did not match what was inside the package. The label was for par... Class II Zimmer Biomet, Inc.
Dec 9, 2015 Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; ... Product on the package label did not match what was inside the package. The label was for part... Class II Zimmer Biomet, Inc.
Dec 2, 2015 Green Mamba Suture Passer There may be a separation and an insufficient weld between the spring and washer. The weld betwe... Class II Biomet, Inc.
Dec 2, 2015 Black Mamba Suture Passer There may be a separation and an insufficient weld between the spring and washer. The weld betwe... Class II Biomet, Inc.
Nov 25, 2015 Gold -Tite Hexed Retaining Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Extra Light Retention Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Hex Try-in Screw (5 pk) Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Preformance Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Cover Screw, Headless Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Provide Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Extra Light Angled Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Temporary Non-Hexed Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Pick-Up Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Pick-Up Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 DAL-RO Threaded Female Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Conical Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain IOL Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical EP Pick-Up Coping (Non-Hexed) Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Prep-tite Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Implant Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Replacement Housing Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Abutment Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant Straight Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical Healing Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Twist Lock TM Straight Transfer Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Index Coping Surgical Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Locator Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental ... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Standard Abutment Temporary Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Standard Abutment Transfer Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC

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.