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.
Showing 27441–27460 of 38,428 recalls
Recalled Item: Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L
The Issue: leakage of conductivity sensors of the Dialog
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Force
The Issue: The Neonate Head protocol with the pediatric kernel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: E.cam or Symbia systems that use foresight detectors - Product
The Issue: E. CAM and Symbia system with foresight detectors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protura Robotic Couch System Software
The Issue: When using the recalled product in split shift
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Americot Blue 1/2" x 1.5" : 20-06S
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Cotton Balls-Strung 3/4" : 30-03 Product Usage:
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Cotton Balls-Strung 1/2" : 30-02 Product Usage:
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Policot 1/2" x 1/2" : 90-06 Product
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Ray-Cot 1/2" x 3" : 60-09 Product
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Ultracot 70 mm x 10090 mm :
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Americot Blue 1/2" x 1/2" : 20-04S
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Americot Blue 3/8" x 2" : 20-26S
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Uniqcot 1/2" x 1/2" : 67-06 Product
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Delicot X 9 mm x 50 mm Ref
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Delicot 10 mm x 13 mm :
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Delicot non-xray 10 mm x 13 mm Ref
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Americot Blue 1/4" x 1.5" : 20-30S
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.