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Updated Recommendations: Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks - FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is providing an update on O&M Halyard surgical N95 respirators and use of existing inventory. On August 9, 2023, O&M Halyard recalled one lot of FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827), because this respirator may not provide adequate filtration protection to the user. The FDA will continue to keep the public informed as new or additional information becomes available

The FDA is committed to communicating with health care providers and the public, when needed, to ensure their health and safety in support of our mission to protect and promote public health.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).