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 27741–27760 of 38,428 recalls
Recalled Item: Curity Gauze 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 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.
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.
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: Hand-Held Scanner USB IT3800 For sample identification and tracking when
The Issue: The hand-held barcode scanner model IT3800 used with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOPAZ MicroDebrider 0.8 mm
The Issue: During functional testing of devices after real time
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Inspection Technologies
The Issue: Radiation emissions which exceeded the limit in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAK Liquid Acrylic Resin sold under the following labels: 1)
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens SOMATOM Definition: Intended to produce cross-sectional images of the
The Issue: Software bugs in these SOMATOM systems could possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens SOMATOM Definition
The Issue: Software bugs in these SOMATOM systems could possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens SOMATOM Definition AS
The Issue: Software bugs in these SOMATOM systems could possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens SOMATOM Definition Flash
The Issue: Software bugs in these SOMATOM systems could possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERION Unit (Vision Planner) Product Usage: The VERION Image
The Issue: Alcon is conducting a voluntary medical device correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is
The Issue: Ferrous material in the SIGNA Pioneer Table Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medica ISE Module Calibrant A
The Issue: Lot was not functioning properly and not exhibiting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gomco Style Circumcision Clamp Trays is an instrument used to
The Issue: Two lots of Gomco Style Circumcision Clamp Trays,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use
The Issue: Endoscope cleaning brush 11276CL may not fit resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RT-5100 (Epic 5100) and RT 3100 : Product Usage:
The Issue: There has been a reoccurrence of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.