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 1961–1980 of 38,428 recalls

June 10, 2025· SEDECAL SA

Recalled Item: RADPRO MOBILE

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Sedecal Mobile Digital Diagnostic X-Ray Systems

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number 40KWMOBILE3.899

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number 40KWFXPLUS.005

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number 40KWFXPLUS.002

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: SED URS LP

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number 40KWFXPLUS

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-Batt

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number 40KWFX

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing
June 10, 2025· SEDECAL SA

Recalled Item: Model Number SM-40HF-B-D-C

The Issue: Sedecal sent an email to its consignees to

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

Class II — Potential Health HazardOngoing