Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 4,896 recalls
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Software issue may cause measurements to be displayed inaccurately.