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 28741–28760 of 38,428 recalls

November 25, 2015· Biomet 3i, LLC

Recalled Item: 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: Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x

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: LDA Screw SBL 4mm(D) Item: SCRSBL2 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 Non-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: Preformance 15 degrees 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: Standard Abutment Transfer 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: Standard Abutment Temporary 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 Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 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 5mm(D) x 5.6mm(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: Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 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 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: Index Coping Surgical 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 Twist Lock TM Straight Transfer 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 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: Conical 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 Implant Straight 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: Locator Abutment 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: 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: Locator Replacement Housing 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 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