FDA Updates Alert on Halyard N95 Masks

FDA is providing further clarification about a safety alert issued earlier this year that recommended against the use of certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with some of their surgical and pediatric face masks. Laboratory tests show these masks “do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer,” the alert said.

Previously, the agency said that, if necessary, the respirators may “continue to be used for respiratory protection when fluid barrier protection against splashes, sprays, or splatter is not needed, such as in non-surgical settings where exposure to liquid, bodily or other hazardous fluids is not expected.” It now says the company has recalled one lot of face masks because they may not provide adequate filtration protection to the user. “This recall is a product removal of the one affected lot,” the agency says, adding that all products from other lots can continue to be used.