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Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
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.
This safety communication provides:
- A list of surgical N95 respirators to stop using.
- A list of surgical masks (including procedure masks) and pediatric face masks to not use when fluid barrier protection against splashes, sprays, or splatter is needed
- Recommendations for consumers, health care providers, and facilities.
- The FDA’s actions to address the issue.
- Instructions for reporting problems to the FDA.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
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