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 27521–27540 of 38,428 recalls
Recalled Item: American Surgical Cotton Balls-Strung 1/8" : 30-07 Product Usage:
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Delicot 20 mm x 60 mm :
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 20 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 Cotton Balls-Non-Strung 1/8" : 31-07 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 3/8" : 30-01 Product Usage:
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 20 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 3/8" x 3/8" : 20-22S
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 3" : 20-07S
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" : 20-05S
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" x 1" : 60-12 Product
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Delicot 4 mm x 50 mm :
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Ultracot 30 mm x 70 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 Uniqcot 1/2" x 3" : 67-09 Product
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Surgical Tonsil Sponges 1" Large : 50-01 Product
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mass Eye & Ear Finger Cot Nasal 2's :
The Issue: Product packaging defective compromising sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q
The Issue: St. Jude Medical is recalling the Ellipse ICD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CF InPlex ASR Card
The Issue: Complaints of false positive HET mutations and leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor...
The Issue: A recent firmware update developed by Medtronic for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hologic InPlex CF Molecular Test (IVD)
The Issue: Complaints of false positive HET mutations and leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Trucount Absolute Counting Tubes: Model number: 340334 IVD
The Issue: One lot of lot of BD Trucount tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.