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 1241–1260 of 38,428 recalls
Recalled Item: NOxBOXi Nitric Oxide Delivery System
The Issue: The unexpected internal fault / system diagnostic error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version
The Issue: that the measured value may be smaller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500
The Issue: The device either indicated a failure of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600
The Issue: The device either indicated a failure of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Juggerknot Mini Soft Anchors
The Issue: The outer carton box label is for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemoLock Closed Vial Spike w/Skirt
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemoLock Port w/Spiros
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemoLock" Port
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemosafeLock Connecter
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical Syringe Transfer Set w/MicroClave
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemoLock Vented Vial Spike
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical Chemo Lock Universal Vented Vial Spike
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical 21" Ext Set w/ChemoLock Port
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical 30" (76 cm) Appx 3.3 mL
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemosafeLock Vial Adapter : KL-VA001U3 KL-VA002U3 KL-VA131U3...
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CellMek SPS Sample Preparation System
The Issue: Automated pipetting, diluting and specimen processing workstations for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical 30" (76 cm) Appx 3.6 ml
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICU Medical ChemoLock Vial Spike
The Issue: Port weld of drug transfer device may separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.