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 29881–29900 of 38,428 recalls
Recalled Item: BD Flow Cytometers
The Issue: Instruments installed between June 2007 and September 2011
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable
The Issue: The Supporter toilet armrest has two Fast Nuts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Stockert Heater-Cooler 3T
The Issue: colonization of organisms, including Mycobacteria, in Sorin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Block Versions Used by Dental Offices often to as
The Issue: 3M is initiating a Field Correction to remove
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE
The Issue: SCFE Drivers of the Free-Gliding SCFE Screw System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
The Issue: There is potential risk of electrical shock if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASP-1020 LipoTower with Aspiration Pump. Medical use.
The Issue: There is potential risk of electrical shock if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OxySure Model 615 disposable replacement cartridges
The Issue: Flow rate of the recalled replacement cartridges does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Precision 500D Classical R & F system.
The Issue: A reported incident of a monitor that fell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Precision RXi 23A/32A Analog System
The Issue: A reported incident of a monitor that fell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Precision RXi Digital system
The Issue: A reported incident of a monitor that fell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.