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 12441–12460 of 38,428 recalls
Recalled Item: ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear.
The Issue: that a limited number of individual contact
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnera 400A Digital Radiographic System
The Issue: There is the potential for the X-Ray system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnera 400T Digital Radiographic System
The Issue: There is the potential for the X-Ray system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display
The Issue: Due to a software error, the user may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WorkMate Claris v.1.2 Upgrade Kits
The Issue: Due to a software error, the user may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System
The Issue: Due to a software error, the user may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuMoDx Cartridge
The Issue: There is a potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens
The Issue: Photometer Lamp May Reach Saturation Without Flagging Results,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angiographic Guidewire Component: Model Number: 107042
The Issue: The component part numbers intended for shipment to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViewRay MRIdian Linac System: Model No. 20000-01 software
The Issue: Software anomalies affecting the French, German and Italian
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage:
The Issue: Ortho investigated and confirmed the potential for unexpected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option
The Issue: Significant wear of the Monitor Bracket Assembly shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.