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 30481–30500 of 38,428 recalls
Recalled Item: regard Item Number: 800413
The Issue: The kits contain an equipment glove component which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard Item Number: 800528001
The Issue: The kits contain an equipment glove component which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard Item Number: 800599
The Issue: The kits contain an equipment glove component which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard Item Number: 800414
The Issue: The kits contain an equipment glove component which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips GoSafe Communicator 7000L Personal emergency response system.
The Issue: Home communicator Model 7000L may not sense the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
The Issue: The Left and Right orientation of the trial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vilex
The Issue: Incidence of breakage is higher than expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AccuChek Spirit Combo insulin infusion pump sold as part of
The Issue: Roche has become aware of an increase of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AccuChek Spirit insulin infusion pump.
The Issue: Roche has become aware of an increase of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vilex
The Issue: Incidence of breakage is higher than expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vilex
The Issue: Incidence of breakage is higher than expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay
The Issue: High invalid rate and an increased risk of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue #
The Issue: GE Healthcare has become aware that 3 bolts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT
The Issue: At a PROBEAT III site installed in Japan,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXPEDIUM Spine System/Synapse System
The Issue: Device does not mate as intended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer
The Issue: Devices were placed in a shipper carton without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultraview SL Command Modules
The Issue: Modules resetting. This failure mode happens when the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Suction Pack - contains Devon Light Glove Used during surgery
The Issue: Convenience kits being recalled due to the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Glaucoma Pack - contains Devon Light Glove Used during surgery
The Issue: Convenience kits being recalled due to the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Knee Arthro Pack and Knee Arthro Pack II - contains
The Issue: Convenience kits being recalled due to the recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.