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 15601–15620 of 38,428 recalls

February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Select

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Hip Cement Spacer Mold with Insert

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Select

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Select

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Knee Femoral Cement Spacer Mold

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Select

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Hip Cement Spacer Mold with Insert

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Knee Tibial Cement Spacer Mold

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Knee Tibial Cement Spacer Mold

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Knee Femoral Cement Spacer Mold

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Knee Tibial Cement Spacer Mold

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Select

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated
February 26, 2020· Biomet, Inc.

Recalled Item: BIOMET StageOne Select

The Issue: Potentially insufficient cleaning process or potential inadequate process

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

Class II — Potential Health HazardTerminated