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 11901–11920 of 38,428 recalls
Recalled Item: Catalog A942216
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A897514
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A800061
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A119216M
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A303318A
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A300318A
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A303316A
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A943216
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A800361
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A800365
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: General Manual surgical instrument
The Issue: Sterility assurance may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A300314A
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A902916
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aspirated Cyto-Histological Biopsy needle
The Issue: Sterility assurance may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A303416A
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bone Marrow Transplantation biopsy needle
The Issue: Sterility assurance may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A319516AM
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK
The Issue: Firm's submission for Emergency Use Authorization (EUA) contained
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A399400A
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog A300316A
The Issue: There is potential for packaging defects that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.