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 13041–13060 of 38,428 recalls
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 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: Instructions for Use and Patient Manual for HeartWare HVAD System.
The Issue: IFU and Patient Manual updated to describe HVAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instructions for Use and Patient Manual for HeartWare HVAD System.
The Issue: IFU and Patient Manual updated to describe Expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instructions for Use and Patient Manual for HeartWare HVAD System.
The Issue: Medtronic HeartWare HVAD System Instructions for Use (IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HVAD Controller
The Issue: There is the potential for the Controller power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker
The Issue: Their is a potential that Video Processor/Illuminators may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HVAD Battery
The Issue: There is the potential for the Controller power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HVAD Monitor Data Cable
The Issue: There is the potential for the Controller power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power Supply: 1. Medtronic HVAD Controller AC Adapter
The Issue: There is the potential for the Controller power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HVAD Alarm Adapter
The Issue: There is the potential for the Controller power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HVAD Packaged Monitor
The Issue: There is the potential for the Controller power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panther Fusion Tube Tray
The Issue: There is a potential for tube trays to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CF Delivery Dev Caps Bravo x5
The Issue: The capsule may fail to attach to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRAVO PH CAPS DELIVERY DEV5-PK
The Issue: The capsule may fail to attach to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosense Webster
The Issue: There is a potential for the hemostatic valve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosense Webster
The Issue: There is a potential for the hemostatic valve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.