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 6401–6420 of 38,428 recalls
Recalled Item: ProxiDiagnost upgrade- A Multi-functional general Radiography and...
The Issue: Issue 1: Mixed Images: The Radio Fluoroscopy (RF)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy...
The Issue: Issue 1: Mixed Images: The Radio Fluoroscopy (RF)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExcelsiusGPS Cannula A
The Issue: Devices may not be rendered sterile due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView
The Issue: Detector may unexpectedly fall due to a component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT
The Issue: Detector may unexpectedly fall due to a component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView X
The Issue: Detector may unexpectedly fall due to a component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total immunoglobulin M (IgM total) IVD
The Issue: for a negative bias with quality control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PANTHER FUSION System The Panther System is an
The Issue: Due to potential false positive Flu B results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Pneumonia Panel Plus (Pneumoplus)
The Issue: Their is a potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Pneumonia Panel (Pneumo)
The Issue: Their is a potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectral CT 7500: Software Version 5.0
The Issue: A software issue that can incorrectly label all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectral CT on Rails: Software Version 5.1.0.X
The Issue: A software issue that can incorrectly label all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sedecal X Optima URS digital mobile diagnostic x-ray system. A
The Issue: Some parts have fallen off the equipment resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiaSorin LIAISON HSV-2 Type Specific IgG
The Issue: DiaSorin has identified that lots 136344, 136344A, 136344B,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product
The Issue: Express chest drains are pre-packaged with sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product
The Issue: Express chest drains are pre-packaged with sterile water
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Articulating Headrest
The Issue: Dual-articulating head rest may not stay in place
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dual Articulating Headrest
The Issue: Dual-articulating head rest may not stay in place
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion system
The Issue: System may exhibit a loss of imaging functionality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: High Frequency Transport Phasitron Breathing Circuit Kit
The Issue: Due to an assembly error within the breathing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.