Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 28681–28700 of 38,428 recalls

November 25, 2015· Biomet 3i, LLC

Recalled Item: IOL Healing Cap Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Certain Standard Abutment Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: IOL Distal Extension Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item:

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Certain Twist Lock TM Coping Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Temporary Hexed Cylinder Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Locator Replacement Males 4pk Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Gold Slotted Screw Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Conical Abutment Gold Standard ZR TM Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Locator Light Retention Replacement Males 4pk Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Conical Abutment Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Preformance Post Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Certain Preformance Temporary Cylinder Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Certain EP Twist Lock TM Coping Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Titanium Hexed Uniscrew Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Gingihue Post Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Gingihue 15 Degree Pre-Angled Post Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: IOL Transfer Impression Coping Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
November 25, 2015· Biomet 3i, LLC

Recalled Item: Titanium Square Uniscrew Dental implants

The Issue: Pouches may not have been sealed during packing

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated