Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 205–216 of 233 recalls
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast.…
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast.…
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".