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 11481–11500 of 38,428 recalls
Recalled Item: Catalys Precision Laser System
The Issue: Aberrometer and precision laser systems are affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of
The Issue: Balloon pinhole results in losss pressure or fails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of
The Issue: Balloon pinhole results in losss pressure or fails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of
The Issue: Balloon pinhole results in losss pressure or fails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures
The Issue: Balloon pinhole results in losss pressure or fails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures
The Issue: Balloon pinhole results in losss pressure or fails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of
The Issue: Balloon pinhole results in losss pressure or fails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of
The Issue: Balloon pinhole results in losss pressure or fails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures
The Issue: Balloon pinhole results in losss pressure or fails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomeme SARS-CoV-2- Real Time RT-PCR Test
The Issue: The current IFU specifies a shelf-life of one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q.zen ceiling with software VD12-angiography systems developed for single
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q floor with software VD12- angiography systems developed for
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q biplane with software VD12-angiography systems developed for single
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee floor with software VD12-angiography systems developed for single
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee ceiling with software VD12-angiography systems developed for single
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q.zen biplane with software VD12- angiography systems developed for
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee biplane with software VD12-angiography systems developed for single
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q ceiling with software VD12-angiography systems developed for single
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q.zen floor with software VD12-angiography systems developed for single
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee multi-purpose with software VD12-angiography systems developed for...
The Issue: If SID (source-to-image distance) lift movement is activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.