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The U.S. Food and Drug Administration (FDA), in response to questions about existing inventory that we have received from health care provider organizations that rely upon O&M Halyard surgical N95 respirators, and informed by testing results available to the FDA, is providing an update to our recommendations in the April 12, 2023, safety communication for one of the surgical N95 respirators. The FDA continues to evaluate all available information about the quality and performance of certain models of surgical N95 respirators, surgical masks, and pediatric face masks manufactured by O&M Halyard. We 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, contact the Division of Industry and Consumer Education.
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