Today, the U.S. Food and Drug Administration (FDA) issued a safety communication recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks by O&M Halyard.
The FDA is aware of laboratory test results that show certain models of O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer. The FDA is continuing its evaluation.