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 31161–31180 of 38,428 recalls
Recalled Item: HeartWare Ventricular Assist System (HeartWare Controller) Product Usage:...
The Issue: The affected clinical trial Controllers exhibit a higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Brainlab Offset Cup Impactor Universal. Part of the Brainlab
The Issue: The recommended sterilization and drying parameters are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis One
The Issue: The possibility exists that the monitor may fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BodyGuard 323 pump
The Issue: CME America is recalling the BodyGuard and BodyGuard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT c4000 Cuvette Segment
The Issue: There is a potential to generate falsely-depressed patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch
The Issue: On 08 January 2015 AMS Sole Customer for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging)
The Issue: On 08 January 2015 AMS Sole Customer for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViewRay System
The Issue: The software was not correctly using the RT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4" Trifurcated set with Bionectors and check valves
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4" Microbore T-Port Set
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4" Microbore Trifurcated Ext set
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6" Trifurcated set with Bionectors
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7" Standard Bore High Pressure Ext Set
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4" Microbore Double Lumen Set with Bionector
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6" Trifurcated Extension Set
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7" High Pressure Set with Bionector
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8" Standard Bore Ext Set
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bifurcated set with check vales and Bionectors
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7" Standard Bore High Pressure Ext Set
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bifircated Extension Set
The Issue: for leaking caused by insufficient bond between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.