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Browse Device Recalls

222 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 222 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 222 FDA device recalls.

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DateProductReasonClassFirm
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous den... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous den... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous den... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous denta... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An en... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental im... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental i... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous denta... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endoss... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implan... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implan... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous d... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous den... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Sep 14, 2016 BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental im... A limited number of product pouches may not have been sealed during packaging. Class II Biomet 3i, LLC
Aug 8, 2016 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only. Product was incorrectly packaged. Class II Biomet 3i, LLC
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

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.