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 13021–13040 of 38,428 recalls
Recalled Item: Cellex qSARS-Cov-2 Antigen Rapid Test
The Issue: The kit does not have an emergency use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyWay Walker Chassis - Product Usage: is intended for use
The Issue: Due to a failure of the welds, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasonic pulsed doppler imaging system - Product Usage: intended for
The Issue: Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
The Issue: In case of a failed automatic marker detection,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) for the following packaging:
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) for the following packaging:
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) kit for the following
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module
The Issue: Bezel repair parts used, not by the original
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) for the following packaging:
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) for the following packaging:
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) for the following packaging:
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) for the following packaging:
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) for the following packaging:
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Guardian Sensor (3) for the following packaging:
The Issue: Use of the continuous glucose monitoring system while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.