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 10161–10180 of 38,428 recalls
Recalled Item: BEQ-HLS 5050 USA
The Issue: The firm has expanded the recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter DISCPAC Syringe Tip Caps
The Issue: There is a potential of the packaging not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter DISCPAC Syringe Tip Caps
The Issue: There is a potential of the packaging not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter DISCPAC Syringe Tip Caps
The Issue: There is a potential of the packaging not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter DISCPAC Syringe Tip Caps
The Issue: There is a potential of the packaging not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter DISCPAC Syringe Tip Caps
The Issue: There is a potential of the packaging not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter DISCPAC Syringe Tip Caps
The Issue: There is a potential of the packaging not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter DISCPAC Syringe Tip Caps
The Issue: There is a potential of the packaging not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin METAFIX HIP STEM
The Issue: One MetaFix size 7 collarless stem from batch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TANDEM LIFE LivaNova LIFESPARC Controller
The Issue: Critical Failure of the LifeSPARC controller when the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Autosoft 90
The Issue: The IFU incorrectly states the insulin fill value
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline CHEST TUBE REORDER NO: DYNJ36762A
The Issue: Due to a non-sterile component (tape) being place
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for...
The Issue: Device does not meet regulatory requirements of stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is
The Issue: Primary Pump Tubing Spare Part is incorrect. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FGFR RGQ RT-PCR Kit (RUO
The Issue: Increased occurrence rate of false positive results, lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: therascreen FGFR RGQ RT-PCR Kit (CE IVD
The Issue: Increased occurrence rate of false positive results, lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: therascreen FGFR RGQ RT-PCR kit (US IVD)
The Issue: Increased occurrence rate of false positive results, lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III Bronchovideoscope
The Issue: The recalled unit was utilized in a veterinary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Critical Care AB/Getinge Servo-u Ventilator System
The Issue: Ventilators may generate a combination of alarms which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUCLISENS easyMAG Magnetic Silica
The Issue: There is a potential of no result leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.