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O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Recalled January 1, 2025 · FDA recall Z-0728-2025 · O&M HALYARD
Hazard
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. · FDA Class II
Units
211 cases
Sold at
Nationwide
Description
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.
Product
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Manufacturer(s)
O&M HALYARD, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →