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 12261–12280 of 38,428 recalls

June 3, 2021· Boston Scientific Corporation

Recalled Item: Essentio pacemaker

The Issue: Latent release of small amounts of hydrogen within

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

Class II — Potential Health HazardOngoing
June 3, 2021· Boston Scientific Corporation

Recalled Item: VISIONIST CRT-P pacemaker

The Issue: Latent release of small amounts of hydrogen within

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

Class II — Potential Health HazardOngoing
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Medtronic Neuromodulation

Recalled Item: Medtronic StimLoc Burr Hole Cover

The Issue: Excess nylon flash on the clip

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

Class II — Potential Health HazardOngoing
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated
June 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter

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

Class II — Potential Health HazardTerminated