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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.

Clear
DateProductReasonClassFirm
Nov 25, 2015 Temporary Healing Retention Cylinder 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 6mm(P) x 4mm(H) Item: IWTH564 Dental i... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Titanium Square Uniscrew Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Transfer Impression Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gingihue 15 Degree Pre-Angled Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gingihue Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue TM 15 degree Angled Post 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 Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental imp... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Preformance Temporary Cylinder Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Preformance Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Light Retention Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical Abutment Gold Standard ZR TM Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gold Slotted Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Locator Replacement Males 4pk Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Temporary Hexed Cylinder 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 Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Denta... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Distal Extension Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Standard Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 IOL Healing Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gold-Tite Square Uniscrew Item: UNISG Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item:... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue 15 degree Angled Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Pick-up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 DAL-RO Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain EP Pick-Up Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 DAL-RO Housing, Female Assembly Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G ... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical EP Twist Lock TM Coping Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Micromini Flat Implant Cover Screw Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Preformance 15 degrees Pre-Angled Post Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Conical EP Healing Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Bellatek Encode Healing Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Conical 17 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental impl... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Conical 25 degree Angled Abutment Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Provide Protection Cap Dental implants Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 25, 2015 Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 ... Pouches may not have been sealed during packing. Class II Biomet 3i, LLC
Nov 16, 2015 Radiographic Transparency for Certain and External Connection Tapered Implant... Images contained within radiographic transparency ART 1036 are undersized. Class II Biomet 3i, LLC
Sep 21, 2015 BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC... Inadequate biocompatibility testing. Class II Biomet 3i, LLC
Sep 21, 2015 BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, ... Inadequate biocompatibility testing. Class II Biomet 3i, LLC
Sep 21, 2015 BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC6... Inadequate biocompatibility testing. Class II Biomet 3i, LLC
Sep 21, 2015 BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654,... Inadequate biocompatibility testing. Class II Biomet 3i, LLC
Aug 10, 2015 Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to ... RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, ... Class II Biomet 3i, LLC
Aug 10, 2015 Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attac... The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a squa... Class II Biomet 3i, LLC
Jul 29, 2015 UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous de... MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexe... 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.