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 28761–28780 of 38,428 recalls

November 25, 2015· Biomet 3i, LLC

Recalled Item: Implant 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: Prep-tite 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: Conical EP Pick-Up Coping (Non-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: 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: Certain IOL 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 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: DAL-RO Threaded Female 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 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: IOL Pick-Up 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: Pick-Up 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: 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: Locator Extra Light Angled 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: Certain Provide 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: Cover Screw

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 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 Hex Try-in Screw (5 pk) 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 Extra Light Retention 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 -Tite Hexed Retaining 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· The Anspach Effort, Inc.

Recalled Item: Battery Power Line II Battery Oscillator

The Issue: Has the incorrect operating directions on the mode

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

Class II — Potential Health HazardTerminated
November 25, 2015· Mako Surgical Corporation

Recalled Item: MAKOplasty Hip Array Kit Laminate 150230

The Issue: Stryker Orthpaedics became aware that there is the

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

Class II — Potential Health HazardTerminated