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 30761–30780 of 38,428 recalls
Recalled Item: Bard Monopty Disposable Core Biopsy Instruments and Kits
The Issue: Bard Peripheral Vascular is recalling the Bard Monopty
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Dual Chamber Temporary External Pacemaker
The Issue: performance issue when used with specific AA-sized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brand Name Burn Navigator¿ Model Numbers: Catalog 1120
The Issue: Battery packs may heat up abnormally and ignite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 16 Power. Computed Tomography X-ray systems intended to
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 40. Computed Tomography X-ray systems intended to produce
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 16 Water. Computed Tomography X-ray systems intended to
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT. Computed Tomography X-ray systems intended to produce...
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 10 Air. Computed Tomography X-ray systems intended to
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 16 Air. Computed Tomography X-ray systems intended to
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 6 Air. Computed Tomography X-ray systems intended to
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT 64. Computed Tomography X-ray systems intended to produce
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity CT. Computed Tomography X-ray systems intended to produce...
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MX8000 Dualv. EXP
The Issue: The firm was informed that while raising the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiaSorin
The Issue: Instability in the PRO-Trac II Tacrolimus ELISA kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natus neoBLUE blanket LED Phototherapy system which includes the following
The Issue: neoBLUE blanket LED Phototherapy System is recalled because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S Surgical System IS2000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S Surgical System IS2000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S Surgical System IS2000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgical System IS3000
The Issue: Cloudy/waxy appearance with potential to transfer waxy substance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.