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 541–560 of 38,428 recalls

November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Inner Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Inner Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Inner Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing
November 11, 2025· Olympus Corporation of the Americas

Recalled Item: Olympus Inner Sheath

The Issue: Complaints of the ceramic tip of the resection

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

Class II — Potential Health HazardOngoing