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 38421–38428 of 38,428 recalls
Recalled Item: GE Healthcare Revolution XR/d
The Issue: An incident was reported that an operator's finger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare
The Issue: An incident was reported that an operator's finger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee
The Issue: An incident was reported that an operator's finger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT (computed tomography) scanners
The Issue: Brilliance Big Bore- An anomaly was identified with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT System 6/10/16/16P/40 configuration. No packaging
The Issue: The system has a gap that can appear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUN|DASH RADIUS 252 tanning system
The Issue: The firm has tracked a systematic failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Prisma 2K Hearing Aid Product Usage: A behind the
The Issue: Siemens became aware of an issue where an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Cart used in conjunction with the da Vinci S
The Issue: Increased number of complaints regarding fluid entering the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.