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 25001–25020 of 38,428 recalls
Recalled Item: MEVATRON M 7400/7440(MEX) Accelerator
The Issue: Siemens became aware of a defective weld seam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVATRON M 6730/6740 (MEX) Accelerator
The Issue: Siemens became aware of a defective weld seam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVATRON MD-2
The Issue: Siemens became aware of a defective weld seam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The UNI-CP System
The Issue: The firm received one complaint from one non-US
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVATRON KD-2
The Issue: Siemens became aware of a defective weld seam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVATRON M 6700 (MX) Accelerator
The Issue: Siemens became aware of a defective weld seam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OP7543 Design Y Mandible Onlay - Medium - Left and
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Heart Tracecart
The Issue: DeRoyal manufactured custom tracecarts containing a sterile Maquet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SRHS DeRoyal Heart Tracecart
The Issue: DeRoyal manufactured custom tracecarts containing a sterile Maquet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Influenza Transport Swab Packages
The Issue: Quidel Corporation is recalling Influenza Transport Swab Packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR Avant-garde
The Issue: Siemens became aware of Incorrect values for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTISTE MV System
The Issue: Siemens became aware of Incorrect values for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMUS Medical charged-particle radiation therapy system Product Usage: The...
The Issue: Siemens became aware of Incorrect values for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge LIS
The Issue: A defect in the software resulted in medications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XTRAC Excimer Laser
The Issue: When the Liquid Guide ( LLG) is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RTI Biologics BioSet IC RT Paste 2 cc Filler
The Issue: Incorrect instructions for use (IFU) included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Premier Guard Drape
The Issue: Sterility compromised due to breach in sterile barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029)
The Issue: Sterility compromised due to breach in sterile barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265
The Issue: The firm information that the product was reporting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CaviWipes1 Extra Large
The Issue: Metrex is recalling the CaviWipes Extra Large because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.