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 16321–16340 of 38,428 recalls
Recalled Item: Reinforced Introducer Sets Maquet 7.5 Fr.
The Issue: for compromised sterility in breached pouches of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP)...
The Issue: Atellica and ADVIA hsCRP calibrator accuracy has drifted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Garbin EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product
The Issue: Atellica CH: The Atellica¿ CH High Sensitivity CReactive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeVent EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EVO Ventilator
The Issue: Software defect in the Trilogy EVO and Trilogy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TandemLife ECLS Procedure Kit - V24/A17
The Issue: The kit contained a 29Fr ProtekDuo cannula instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G6 CGM App for iOS Software Number:
The Issue: It was reported that the user's low alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT
The Issue: May result in readings outside of the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product
The Issue: May result in readings outside of the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.