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 7781–7800 of 38,428 recalls
Recalled Item: Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK
The Issue: The outer package seal could be open, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom medical procedure packs labeled as: a) OPEN HEART TRACECART
The Issue: The outer package seal could be open, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY
The Issue: The outer package seal could be open, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI
The Issue: The outer package seal could be open, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: .14.800
The Issue: Due to manufacturing issue, their is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: .14.500
The Issue: Due to manufacturing issue, their is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level...
The Issue: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an
The Issue: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level...
The Issue: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway
The Issue: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level...
The Issue: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abiomed 14Fr Low Profile Introducer Set
The Issue: There was one complaint that the sidearm of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be
The Issue: Manufactured with the incorrect component may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to
The Issue: Manufactured with the incorrect component may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexiva Pulse ID-intended to be used as a device that
The Issue: Manufactured with the incorrect component may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as
The Issue: Manufactured with the incorrect component may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexiva Pulse ID-intended to be used as a device that
The Issue: Manufactured with the incorrect component may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be
The Issue: Manufactured with the incorrect component may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be
The Issue: Manufactured with the incorrect component may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Slick Set Uncuffed Endotracheal Tube and Stylet Set
The Issue: Reports of disconnection of the 15mm connector from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.