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 34761–34780 of 38,428 recalls
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream Vue PACS
The Issue: Carestream Health, Inc. has issued a recall when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part
The Issue: Roche COBAS INTEGRA 800 system, Software Version 9864.C2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I.
The Issue: PENTAX Medical has become aware of a product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences EMBOL-X Glide Protection System
The Issue: Edwards Lifesciences is recalling certain lots of EMBOL-X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAR Excimer Laser System with Variable Spot Scanning
The Issue: This corrective action will address an identified failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAR ActiveTrak Excimer Laser System
The Issue: This corrective action will address an identified failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAR Excimer Laser System
The Issue: This corrective action will address an identified failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAR Excimer Laser System
The Issue: This corrective action will address an identified failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSet¿ Endurance GMV
The Issue: The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers:
The Issue: Sekisuki Diagnostics has issued a Product Correction for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.