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 20701–20720 of 38,428 recalls
Recalled Item: NxStage Express Fluid Warmer (FW-300
The Issue: There is a potential risk of electrical fire
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve with Pulse Wave Cassette
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centron Product Usage: Vascular
The Issue: The first time an operator selects a new
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNIQ Product Usage: Vascular
The Issue: The first time an operator selects a new
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper Product Usage: Vascular
The Issue: The first time an operator selects a new
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve with Pulse Wave Cassette
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve with Pulse Wave Cassette
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards SAPIEN 3 Transcatheter Heart Valve (THV)
The Issue: SAPIEN 3 THV was packaged with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve with Pulse Wave Cassette
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED-RX
The Issue: The product may be packaged with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroline Trumpet Valve with Pulse Wave Cassette
The Issue: The suction valve may not close properly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchro2
The Issue: The product labels (pouch and carton) for products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchro2
The Issue: The product labels (pouch and carton) for products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchro2
The Issue: The product labels (pouch and carton) for products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.