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 24101–24120 of 38,428 recalls
Recalled Item: XARIO 200 TUS-X200 diagnostic ultrasound system
The Issue: When Continuous Trace method is used as the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XARIO 100 TUS-X100 diagnostic ultrasound system
The Issue: When Continuous Trace method is used as the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800
The Issue: When Continuous Trace method is used as the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APLIO 300 TUS-A300 diagnostic ultrasound system
The Issue: When Continuous Trace method is used as the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Willscher Vas Reapproximator Set
The Issue: COOK Medical is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LapSac Introducer
The Issue: COOK Medical is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Willscher Vas Reapproximator Plate
The Issue: COOK Medical is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartMonitor 2 PS/PSL
The Issue: Circadiance has determined that it is possible for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LapSac Introducer Set
The Issue: COOK Medical is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Willscher Vas Skewers
The Issue: COOK Medical is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscopic Curved Needle
The Issue: COOK Medical is initiating a voluntary recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring
The Issue: Mindray has received two reports from outside the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM IM NAIL 14MMDX30CM LEFT
The Issue: Zimmer Biomet is initiating a field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSA-FXII SC TUBE PLT 90DX16H
The Issue: Zimmer Biomet is initiating a field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z NAIL PF 14MM X 46CM UNIV Z NAIL GT
The Issue: Zimmer Biomet is initiating a field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSA-FX II STD TUBE 130DX16H
The Issue: Zimmer Biomet is initiating a field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM IM NAIL 15MMDX30CM
The Issue: Zimmer Biomet is initiating a field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIBIAL I/M NAIL 15MMDX26CM
The Issue: Zimmer Biomet is initiating a field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.5 BROAD SCP PLT 26-H STER
The Issue: Zimmer Biomet is initiating a field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monica Novii Wireless Patch System product Usage: Novii Interface -
The Issue: Monica Novii Wireless Patch System-Potential battery damage and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.