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 3881–3900 of 38,428 recalls
Recalled Item: Abbott Alinity m HPV AMP Kit
The Issue: Abbott has identified an increase of incidences regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity m STI AMP Kit
The Issue: Abbott has identified an increase of incidences regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn Life2000 Ventilation System
The Issue: The Life2000 ventilator may fail to initiate the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Synapsys Informatics Solution with software versions: 4.20
The Issue: Synapsys software versions 4.20, 4.30, 5.10, 5.20, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroPass Ureteral Access Sheaths Product Name: Ureteral Access
The Issue: Exposure of the UroPass product to Ultraviolet (
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SynchroMed II Infusion Pump. Product Number: 8637-20
The Issue: for error and inability to interrogate pump
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK Universal Handle
The Issue: Some lots of the LINK Universal Handle, with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iCast Covered Stent
The Issue: There is an error in the Unique Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx
The Issue: Safety glasses with Rx indoor universal lenses fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment
The Issue: X-ray R/F system software with certain versions of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The FLUOROspeed is intended to be used as a universal
The Issue: X-ray R/F system software with certain versions of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinias unity
The Issue: If digital angiography system is used with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific myLUX Patient Application for an Apple Mobile device
The Issue: Patients using the Model 2939 myLUX Patient Application
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enterprise Imaging XERO Viewer- software application used for and
The Issue: Software defect, when an image has non-square pixel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Thyroglobulin Antibody II
The Issue: IFUs for the device incorrectly states the biotin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific AVVIGO+ Multi-Modality Guidance System
The Issue: Boston Scientific has received reports indicating the grid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific AVVIGO+ Multi-Modality Guidance System
The Issue: Boston Scientific has received reports indicating the grid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific AVVIGO+ Multi-Modality Guidance System
The Issue: Boston Scientific has received reports indicating the grid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific AVVIGO+ Multi-Modality Guidance System
The Issue: Boston Scientific has received reports indicating the grid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific AVVIGO+ Multi-Modality Guidance System
The Issue: Boston Scientific has received reports indicating the grid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.