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 22561–22580 of 38,428 recalls

October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: Radial Head Assy Size #2

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead Stem Implant Plasma Coated

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: radial head implant #2 (Sterile packed). Orthopedic implant for replacement

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead Stem Implant 6mm Collar

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: Lat Assembly

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: Lateral Assembly

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: Lateral Assembly

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: Lateral Assembly

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: radial stem implant #2 (Sterile packed). Orthopedic implant for replacement

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead Recon Extended Stem Size 2. Orthopedic implant for replacement

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead Recon Stem Implant 6mm Collar

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead Stem Implant Plasma Coated

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: Lat Assembly

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead Standard Extended Stem

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: Radio Capitellum Small

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead Recon Stem Implant 6mm Collar

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Howmedica Osteonics Corp.

Recalled Item: rHead Recon Stem Implant Plasma Coated

The Issue: Revision rate identified as higher than other proximal

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

Class II — Potential Health HazardTerminated
October 24, 2017· Arrow International Inc

Recalled Item: Pneumothorax Kit

The Issue: Product packaging may not be completely sealed

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

Class II — Potential Health HazardTerminated