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 21521–21540 of 38,428 recalls
Recalled Item: BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19
The Issue: Products do not meet the labeled sterility claim
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19
The Issue: Products do not meet the labeled sterility claim
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First aid/emergency kits containing Honeywell eyewash: CSM kit number...
The Issue: Firm is recalling first aid/emergency kits and cabinets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYTEC 288 System
The Issue: Reports when using Rheumatoid Factor test kits, control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE
The Issue: Teleflex Medical is recalling the affected product because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stem Extractor f/Guide Bar
The Issue: There is a potential for the connection screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nobel Biocare 17¿ Multi-Unit Abutment
The Issue: The product label has missing information, such as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACS-NT
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns TCM II
The Issue: Update to cooler-heater cleaning instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T5-NT
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 0.5T Standard
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multiva systems
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conversion SmarthPath to dStream for 1.5T
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T: 1) Nova (Dual)
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T10-NT
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panorama 1.0T
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Lunar: a) DPX NT
The Issue: Under certain conditions, when using DICOM Worklist along
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multiva systems
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T CX
The Issue: risk for helium gas inside the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Lunar: a) DPX Duo
The Issue: Under certain conditions, when using DICOM Worklist along
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.