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 15741–15760 of 38,428 recalls
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL90 FLEX PLUS Analyzer
The Issue: The firm received reports of occurrences where the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL90 FLEX Analyzer
The Issue: The firm received reports of occurrences where the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal PS Knee Replacement System
The Issue: A limited number of tibial trays were labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal CR Knee Replacement System
The Issue: A limited number of tibial trays were labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM
The Issue: The company identified potential interference from hydroxyurea. Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4
The Issue: The company identified potential interference from hydroxyurea. Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM
The Issue: The company identified potential interference from hydroxyurea. Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit
The Issue: Custom surgical kits contain a plate different than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUMATCH Orthognathics - Genioplasty Surgical Kit
The Issue: Custom surgical kits contain a plate different than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LDI Laser firmware lower than V02.13.00 for LDI models: LDl-7
The Issue: The defect relates to firmware version lower than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581...
The Issue: Failure of cardiovascular clips to provide sufficient occlusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574...
The Issue: Failure of cardiovascular clips to provide sufficient occlusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567...
The Issue: Failure of cardiovascular clips to provide sufficient occlusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile
The Issue: Failure of cardiovascular clips to provide sufficient occlusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource Procedure Packs containing AAMI Level 3 surgical gowns
The Issue: The kits contained recalled surgical gowns. The gowns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UST-2265-2 Probe
The Issue: These 18 probes may have mis-wiring in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource Procedure Packs containing AAMI Level 3 surgical gowns
The Issue: The kits contained recalled surgical gowns. The gowns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.