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 1921–1940 of 38,428 recalls
Recalled Item: GYN LAPAROSCOPY PACK. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEN LAPAROSCOPY PACK. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAPAROSCOPY PACK. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAJOR THORACOSCOPY BASIN. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIAC ROBOT PACK. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DAVINCI UROLOGY. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GS ENDOSCOPY PACK. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CT DAVINCI. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DA VINCI PACK URO/PROSTATE. Medical convenience kit.
The Issue: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the
The Issue: Devices had an unapproved slabbing software function enabled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV.
The Issue: The HSG Procedure Trays and Endosee System Convenience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System...
The Issue: The HSG Procedure Trays and Endosee System Convenience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray
The Issue: The HSG Procedure Trays and Endosee System Convenience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Caphosol Artificial Saliva (32 doses sachet box). 64 x 15
The Issue: Out of specification stability test result for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number SM-40HF-B-D-C
The Issue: Sedecal sent an email to its consignees to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SM_40HF_B_D_VIR3
The Issue: Sedecal sent an email to its consignees to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SM_40HF_BDC3
The Issue: Sedecal sent an email to its consignees to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number SM-20HF-Batt
The Issue: Sedecal sent an email to its consignees to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.