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 25961–25980 of 38,428 recalls
Recalled Item: Autolube-III Product Usage: Pneumatic system
The Issue: Supplied Directions for Use (DFU) did not contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCC Soft Computer Softbank II software Product Usage: Supports single
The Issue: Software error. Potential for incorrect results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Softbank software Product Usage: Decision support software for transfusion...
The Issue: Software error. Potential for incorrect results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PAXWIRE Occlusion Balloon System consists of an occlusion catheter
The Issue: AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287
The Issue: The device defect is a positive bias of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218
The Issue: Complaint that during insertion of the dilator through
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.