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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.