Date Issued: April 12, 2023
The U.S. Food and Drug Administration (FDA) is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured 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. Surgical masks referenced in this communication include masks that are labeled by the manufacturer as surgical or procedure masks. These types of masks are intended to provide fluid barrier protection. The FDA is continuing its evaluation.
Source: Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication | FDA