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 3161–3180 of 38,428 recalls
Recalled Item: ACCOLADE DR Pacemaker
The Issue: A subset of devices from the ACCOLADE Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VISIONIST CRT-P
The Issue: A subset of devices from the ACCOLADE Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella RP with SmartAssist
The Issue: Optical Sensors have been damaged due to physical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTRUA 2 DR Pacemaker
The Issue: A subset of devices from the ACCOLADE Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicoVention Terumo
The Issue: for Polytetrafluoethylene (PTFE) material encasing the stent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biological
The Issue: Spore test strip monitoring system, designed for routine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nuwellis AquaFlexFlow UF 500 Plus
The Issue: The AquaFlexFlow UF 500 Plus extracorporeal blood circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic NanoCross Elite PTA catheter
The Issue: There is the potential for in-vivo balloon deflation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neo-Tee T-Piece Resuscitator
The Issue: Gas powered emergency resuscitator has a circuit flow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Idylla INSTRUMENT
The Issue: False-positive MSI-H results generated by the Idylla MSI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR 3D Knee Tibial Insert
The Issue: Knee insert package may contain an acetabular system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JMC5A Ni/TruAire-5 Oxygen Concentrator
The Issue: Oxygen concentrator may melt or catch on fire
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000.
The Issue: for two issues: 1. Bent or detached
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model...
The Issue: for two issues: 1. Bent or detached
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temporary Titanium Abutments
The Issue: Certain definitive dental implant restoration cases may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: pneumatic valve failure that may cause the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portrait Core Services
The Issue: There is a software issue that can result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Product Name: VITROS Chemistry Products
The Issue: Hemoglobin interference may occur at concentrations lower than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Product Name: VITROS Chemistry Products
The Issue: Hemoglobin interference may occur at concentrations lower than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dialyzer Optiflux 160NRe
The Issue: for internal blood leaks due to cracked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.