medical Class II Updated 2025-01-01

O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Di

Recalled Product

O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18
View official government recall

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