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 7241–7260 of 38,428 recalls
Recalled Item: CVS PCSU SJH
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pediatric Heart SJH
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cath Cardiac Pack
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sub Q Recorder Pack
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Robotics Pack
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breast Plastics Pack
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pediatric Urology Wolson Pack
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: General Pack
The Issue: During an internal investigation, ACS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star
The Issue: In some cases, when lubricating grease is present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zephyr Endobronchial Valve (EBV) 5.5-LP
The Issue: Endobronchial implant devices may have been labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroPICC 5Fr Dual Lumen
The Issue: Specific lots of the Dual Lumen HydroPICC Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroPICC 5Fr Dual Lumen Maximal Barrier Kit
The Issue: Specific lots of the Dual Lumen HydroPICC Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EarlyVue VS30 Vitals Monitor
The Issue: A software issue prevents the monitor from alarming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EarlyVue VS30 Vital Signs Monitor
The Issue: A software issue prevents the monitor from alarming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT
The Issue: The firm conducting a recall due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProCuity bed series
The Issue: Patient beds are missing test values for electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProCuity bed series
The Issue: Patient beds are missing test values for electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProCuity bed series
The Issue: Patient beds are missing test values for electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProCurity bed series
The Issue: Patient beds are missing test values for electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProCuity bed series
The Issue: Patient beds are missing test values for electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.