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 27501–27520 of 38,428 recalls

March 31, 2016· American Surgical Company

Recalled Item: American Surgical Telfa 1/2" x 1.5" : 80-08 Product

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Delicot 30mm x 70mm Product Usage:

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ray-Cot 3" x 3" : 60-15 Product

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ray-Cot 1/2" x 1.5" : 60-08 Product

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Delicot non-xray 5 mm x 8 mm Ref

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ray-Cot 1/4" x 3" : 60-04 Product

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Delicot-J 15 mm x 20 mm :

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Policot 1/2" x 1.5" : 90-08 Product

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ultracot 5 mm x 8 mm :

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Americot Blue 3/8" x 3/4" : 20-14S

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ultracot 13 mm x 60 mm :

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Delicot 5 mm x 13 mm :

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Telfa 1" x 3" : 80-13 Product

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Americot Blue 1/8" x 1/8" : 20-19S

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ray-Cot 1" x 3" : 60-13 Product

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Delicot-J 13 mm x 60 mm :

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Ultracot 20 mm x 60 mm :

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated
March 31, 2016· American Surgical Company

Recalled Item: American Surgical Delicot X 6 mm x 50 mm Ref

The Issue: Product packaging defective compromising sterility

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

Class II — Potential Health HazardTerminated