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 35501–35520 of 38,428 recalls

June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Biomet, Inc.

Recalled Item: Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia

The Issue: Biomet investigation found the design of the tibial

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

Class II — Potential Health HazardTerminated
June 7, 2013· Baxter Healthcare Corp.

Recalled Item: Intermate Infusion Pump. Indicated for the intravenous administration

The Issue: Baxter Healthcare Corporation (Baxter) is issuing an Urgent

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

Class II — Potential Health HazardTerminated
June 7, 2013· Baxter Healthcare Corp.

Recalled Item: Regional Analgesia Infusor System with Patient Control. Indicated

The Issue: Baxter Healthcare Corporation (Baxter) is issuing an Urgent

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

Class II — Potential Health HazardTerminated
June 7, 2013· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic

The Issue: Medtronic recently identified an issue with a subset

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

Class II — Potential Health HazardTerminated
June 7, 2013· Baxter Healthcare Corp.

Recalled Item: Intermate Infusion Pump. Indicated for the intravenous administration

The Issue: Baxter Healthcare Corporation (Baxter) is issuing an Urgent

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

Class II — Potential Health HazardTerminated
June 7, 2013· Baxter Healthcare Corp.

Recalled Item: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's

The Issue: Due to an increase in complaints for leaks

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

Class II — Potential Health HazardTerminated