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 36901–36920 of 38,428 recalls

October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux BacT/ALERT Combo Module

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux BacT/ALERT Control Module

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux BacT/ALERT Combo Module

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux BacT/ALERT Control Module

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux BacT/ALERT 3D 60

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux BacT/ALERT Combo Module

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Biomerieux Inc

Recalled Item: bioMerieux Kit

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
October 16, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management

The Issue: Based on a retrospective review of quality data,

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

Class II — Potential Health HazardTerminated