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 28721–28740 of 38,428 recalls

November 25, 2015· Biomet 3i, LLC

Recalled Item: Standard Abutment Pick -Up 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: Implant 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: Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 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 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: Conical EP Pick-Up Coping (Hexed) 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 17 degree Angled 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: Prep-Tite 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 Flat Implant Cover 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: Certain Titanium Large Hexed 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: EP Healing 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: Certain 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: Locator 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: Certain Straight Pick Up 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: Certain EP Healing 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: Certain Non-Hexed Implant Pick-up 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: IOL Titanium 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: O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 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 Extended Range 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: O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 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 Pick-up 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