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 28561–28580 of 38,428 recalls
Recalled Item: RadSuite
The Issue: incorrect Standardized Uptake Values (SUV) measurements in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Inspection Technologies
The Issue: GE Inspection Technologies, LP ("GE") has discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid and rescue IABP
The Issue: Maquet has recieved information that in some Cardiosave
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF
The Issue: There were two potential interference conditions identified with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended
The Issue: Due to Operator Console software anomaly, a change
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A
The Issue: An issue with the Panorama Central Station may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
The Issue: The door latch may not fully close and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lipogems SPA Aspiration Cannulae
The Issue: The cannulae may bend during procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-10 Rack Loader
The Issue: On a rare occasion, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: The Drive Gas Check Valve of certain Anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: The Drive Gas Check Valve of certain Anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: The Drive Gas Check Valve of certain Anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: The Drive Gas Check Valve of certain Anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia device service kits. ASSY-MSN
The Issue: The Drive Gas Check Valve of certain Anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: The Drive Gas Check Valve of certain Anesthesia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Viper LT software
The Issue: BD has confirmed reports that lower than expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mizuho OSI Trios
The Issue: Table Bases may have been assembled incorrectly, missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FMC7 FITC
The Issue: Becton, Dickinson and Company (BD) has determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI¿ H/S Cuvette The intended use for the CDI¿ H
The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.