Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 37 recalls
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care.…
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care.…
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay t…
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay t…
Incorrect expiration date
Labeling error, Incorrect expiration date
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.