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 7041–7060 of 38,428 recalls
Recalled Item: EVO+VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO+VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO+VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 3000 PAK - pH
The Issue: Internal testing identified that the GEM Premier PAKs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 3000 PAK - pH
The Issue: Internal testing identified that the GEM Premier PAKs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IRON assay
The Issue: A high recovery of Iron assay has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity c Iron Reagent
The Issue: A high recovery of Iron assay has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM Premier 3000 PAK - pH
The Issue: Internal testing identified that the GEM Premier PAKs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 15
The Issue: Their is a potential for battery pins to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO EMPOWR Knee Punch Handle
The Issue: Knee punch handle tip is breaking during surgery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP
The Issue: Fiberscopes do not have adequate data to support
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.