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 27721–27740 of 38,428 recalls
Recalled Item: ADVIA Chemistry Triglyceride_2
The Issue: Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Estradiol II Elecsys and cobas e analyzers 190
The Issue: Due to the risk of a recently identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRIdian ViewRay Radiation Therapy System
The Issue: When editing the isocenter or the couch position
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear
The Issue: In rare cases the VERO/MHI-TM2000 Operator Console could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Estradiol III
The Issue: Due to the risk of a recently identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application
The Issue: The AutoSPECT Pro application was only designed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extended Brilliance Workspace NM Special Nuclear medicine image display and
The Issue: The AutoSPECT Pro application was only designed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extended Brilliance Workspace NM Nuclear medicine image display and processing
The Issue: The AutoSPECT Pro application was only designed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management
The Issue: Complaints were received of restricted/inaccurate flow rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardian II Hemostasis Valve
The Issue: Vascular Solutions became aware of a potential problem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Spectra-System Dental Implant 2008 system is comprised of dental
The Issue: Implant Direct Sybron Manufacturing, LLC is recalling GoDirect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bigger-Better-Bladder With 3/8" ID tubing
The Issue: The seal between the balloon and the housing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: dynarex Specimen Containers
The Issue: Exterior carton is mis-labeled as Sterile. Non-sterile, bulk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vistec X-Ray Detectable Sponges
The Issue: Compromised sterility due to breach of barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curity X-Ray Detectable Laparotomy Sponges
The Issue: Compromised sterility due to breach of barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curity All Purpose Sponges
The Issue: Compromised sterility due to breach of barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curity X-Ray Detectable Laparotomy Sponges
The Issue: Compromised sterility due to breach of barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vistec X-Ray Detectable Sponges
The Issue: Compromised sterility due to breach of barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curity X-Ray Detectable Laparotomy Sponges
The Issue: Compromised sterility due to breach of barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kerlix" X-Ray Detectable Laparotomy Sponges
The Issue: Compromised sterility due to breach of barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.