O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
- Recall date
- November 8, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0728-2025
- FDA classification
- Class II
- Brand / firm
- O&M HALYARD, INC.
- Sold / distributed
- Nationwide
Why it was recalled
Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
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