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 1841–1860 of 38,428 recalls

June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE Signa Voyager

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE Discovery MR750 3.0T

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE Discovery MR450 1.5T

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Hero XT (China Only)

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA PET/MR

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Artist Evo

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA PET/MR AIR (China Only)

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Hero Elite (China Only)

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Voyager AIR (China Only)

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA PET/MR AIR Plus (China Only)

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Hero MAX (China Only)

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Architect AIR (China Only)

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Premier MAX (China Only)

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Architect

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE Discovery MR750w 3.0T

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Premier

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE Optima MR450w 1.5T

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA UHP

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· GE Medical Systems, LLC

Recalled Item: GE SIGNA Hero

The Issue: GE HealthCare has become aware that for certain

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

Class II — Potential Health HazardOngoing
June 20, 2025· Intersurgical Inc

Recalled Item: One-piece Guedel airway

The Issue: contamination with small burrs, which if detach

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

Class II — Potential Health HazardOngoing