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 12381–12400 of 38,428 recalls
Recalled Item: Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor
The Issue: Device fail to detect Brady episodes, Pause (Asystole)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit
The Issue: One lot number of a specific model of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Angio Cath Removal Tray
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExacTrac Dynamic software
The Issue: Display of potential patient movement might be delayed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Heart Cath Procedure Pack
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Pacemaker Tray Pgybk
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1300 Analyzer - multi-component system for in vitro
The Issue: Valves used on the Atellica CH 930, Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic
The Issue: Valves used on the Atellica CH 930, Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH 930 Analyzer - multi-component system for in vitro
The Issue: Valves used on the Atellica CH 930, Atellica
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip
The Issue: Labeling does not include guidance for proper water-quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip
The Issue: Labeling does not include guidance for proper water-quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip
The Issue: Labeling does not include guidance for proper water-quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioQuip
The Issue: Labeling does not include guidance for proper water-quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gore Propaten Vascular Graft configured for Pediatric Shunt
The Issue: Vascular Grafts containing an inner diameter of 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gore Propaten Vascular Graft configured for Pediatric Shunt
The Issue: Vascular Grafts containing an inner diameter of 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures
The Issue: Medical devices intended for use in a healthcare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proform- support surface is used to assist in the prevention
The Issue: Medical devices intended for use in a healthcare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation
The Issue: Medical devices intended for use in a healthcare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S3 MedSurg Bed - intended to support and transport patients
The Issue: Medical devices intended for use in a healthcare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Michael Graves with Stryker Highback Chair-intended for pediatric and adult
The Issue: Medical devices intended for use in a healthcare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.