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 8281–8300 of 38,428 recalls
Recalled Item: CRTD CROME HF QUAD MRI IS4 DF4
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-VR DVAB1D4 VISIA AF US DF4
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD COBALT VR MRI IS1 DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTPA2D1G COBALT XT HF QUAD OUS
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Walnut Wearable Smart Thermometer
The Issue: There have been reports of skin burns to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and
The Issue: If cartridges of the affected Serial numbers (SNs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: vRad PACS with Mammography
The Issue: The error resulted in intermittent failure of current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFire Respiratory Panel 2.1 (RP2.1)
The Issue: Due to manufacturing issue, panels may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Pneumonia Panel (Pneumo)
The Issue: Due to manufacturing issue, panels may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.
The Issue: to cause biased results in the upper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tearaway Introducer Kit
The Issue: Sheath introducer assemblies could potentially, due to improper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Tempus LS-Manual Defibrillator
The Issue: Defibrillator/pacemaker module (DPM) may encounter a problem causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tearaway Introducer Set
The Issue: Sheath introducer assemblies could potentially, due to improper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bellavista 1000e Ventilator
The Issue: Vyaire Medical identified two patient safety risks during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bellavista 1000 Ventilator
The Issue: Vyaire Medical identified two patient safety risks during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Medical Linear Accelerator (ELMA) included in the below platforms:
The Issue: A component within a limited number of Elekta
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Betta Link LG Reusable Fishmouth Guide-Intended for use in soft
The Issue: Drill guides might bend when axial forces are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.