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 11421–11440 of 38,428 recalls
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: Manufacturing assembly error where a capacitor within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INBONE Total Ankle System
The Issue: The package contents and package labeling do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INBONE Total Ankle System
The Issue: The package contents and package labeling do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger
The Issue: The wireless rechargers (WR; WR9200 and WR9220; included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger
The Issue: The wireless rechargers (WR; WR9200 and WR9220; included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OCT-Camera 211 01 A3
The Issue: Malfunction of the automatic laser beam shut-off, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OCT-Camera 211 01 A1
The Issue: Malfunction of the automatic laser beam shut-off, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Microsystems M220 F12 Microscope Systems
The Issue: In May 2021, Leica Microsystems received one (1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be...
The Issue: Mating incompatibility between the Inserter Shaft and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
The Issue: Use of a TJF-Q180V with adhesive deterioration or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.