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 7661–7680 of 38,428 recalls
Recalled Item: SENSATION PLUS 8Fr. IAB
The Issue: During IAB catheter insertion, the introducer dilator may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFX-8000C XGCP-930AA TABLE SIDE CONSOLE
The Issue: The C-arm, used to set the position and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use
The Issue: The STATCLAVE G4 is a dynamic air removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fusion Lithotripsy Extraction Basket
The Issue: Non-conforming product may appear in the field as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gore Tips Set Device
The Issue: Three lots of product may be labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fusion Lithotripsy Extraction Basket
The Issue: Non-conforming product may appear in the field as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use
The Issue: The STATCLAVE G4 is a dynamic air removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use
The Issue: (1) There is vial to vial variation resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HoverMatt
The Issue: 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A901 Communication Manager Application
The Issue: When an update to the A710 Clinician Programmer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ringed DxI Reaction Vessels (RVs)
The Issue: Beckman Coulter, Inc. is recalling Ringed DxI Reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS pheno-Angiography systems developed for single and biplane diagnostic...
The Issue: Due to a hardware issue in the cable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS icono floor-Angiography systems developed for single and biplane...
The Issue: Due to a hardware issue in the cable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS icono biplane -Angiography systems developed for single and biplane
The Issue: Due to a hardware issue in the cable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProPlan CMF Patient-Specific Guide
The Issue: Wrong versions of guides 3A and 3B (Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM FLOW COUPLER Monitor
The Issue: An issue was identified where the LCD monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONFORMIS HIP-SCREW-6.5MM X 25MM
The Issue: 30mm screws were labeled as 25mm screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaPlus Infant Heel Warmer
The Issue: Cardinal Health has received an increase in burst/leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DOLOMITE GLOSS ROLLATOR - intended to support during walking and
The Issue: Premature failure of the seat during use, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE Suction Coagulators
The Issue: An issue with the Suction Coagulator product family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.