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 28661–28680 of 38,428 recalls

November 25, 2015· Biomet 3i, LLC

Recalled Item: Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44

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: Provide Protection 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 Conical 25 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: Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G

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 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: Certain Bellatek Encode 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 Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 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 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 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: Certain Micromini 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: Conical 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: Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H)

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: DAL-RO Housing

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 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: DAL-RO 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 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 Gingihue 15 degree 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: Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P)

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 Square Uniscrew Item: UNISG 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: LDA Screw SBL 3mm(D) Item: SCRSBL1 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