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 12161–12180 of 38,428 recalls
Recalled Item: NEO DELTA SELFSAFE PUR T
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO DELTA Self Safe T
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO DELTA SELFSAFE PUR T
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WOLF-PAK Self Safe Safety IV Catheter: a) b)
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELTAVEN Safety I.V. Catheter in Pur with closed system: a)
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELTAVEN FASTFLASH
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO DELTA SELFSAFE PUR 1
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELTAVEN Y
The Issue: Problems related to the sterilization of the medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien HysteroLux Fluid Management System Control Unit
The Issue: When the display of inflow volume to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the
The Issue: Out of Specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and
The Issue: It has been identified that ventilators equipped with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10.
The Issue: It has been identified that ventilators equipped with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ilizarov Wire Tensioner
The Issue: Medicalplastic s.r.l. is conducting a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemotherm CE Dual Reservoir Cooler/Heater
The Issue: There is a potential risk of device contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part
The Issue: The current Argyle UVC Insertion Tray does not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites
The Issue: There is a discrepancy in the expiry date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235- designed to produce and deliver a proton beam
The Issue: Users may be misled by the popup message
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard NEWBORN KIT
The Issue: Instructions for use updated to include the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard NEWBORN KIT
The Issue: Instructions for use updated to include the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.