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 12241–12260 of 38,428 recalls
Recalled Item: HeartWare HVAD Pump Implant Kit
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Implant Kit
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Outflow Graft
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Accessories
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Driveline Extension Cable
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Implant Kit
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Implant Kit
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Implant Kit
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Implant Kit
The Issue: Medtronic is stopping the distribution and sale of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BULKAMID
The Issue: Lack of Sterility Assurance; needle in procedure pack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INLIVEN CRT-P
The Issue: The dual chamber INGENIO family pacemakers or cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VALITUDE CRT-P pacemaker
The Issue: Latent release of small amounts of hydrogen within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTUA CRT-P
The Issue: The dual chamber INGENIO family pacemakers or cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INGENIO DR EL (pacemakers)
The Issue: The dual chamber INGENIO family pacemakers or cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altrua 2 pacemaker
The Issue: Latent release of small amounts of hydrogen within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVANTIO DR EL (pacemaker)
The Issue: The dual chamber INGENIO family pacemakers or cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INVIVE CRT-P
The Issue: The dual chamber INGENIO family pacemakers or cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proponent pacemaker
The Issue: Latent release of small amounts of hydrogen within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITALIO DR EL (pacemaker)
The Issue: The dual chamber INGENIO family pacemakers or cardiac
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accolade pacemaker
The Issue: Latent release of small amounts of hydrogen within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.