O&M HALYARD, INC. is recalling 250 cases (approximately 75,000 pieces) of HALYARD SURGICAL HOODS in a universal blue size. These medical products were incorrectly labeled as a "Surgical Cap" at the dispenser level rather than their actual classification as a surgical hood. This mislabeling could lead healthcare workers to select the wrong protective equipment for clinical procedures, potentially affecting sterile protocols.
The mislabeling of a surgical hood as a surgical cap may cause confusion for medical staff during equipment selection. This error could result in the use of incorrect personal protective equipment during surgery or other sterile procedures, which may increase the risk of contamination or insufficient coverage.
Manufacturer guidance
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Sources: FDA iRES · Raw API Response
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