medical Class II Updated 2025-01-01

O&M HALYARD, INC. recalls O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable sur

Recalled Product

O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500


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: 20680651475002 Lot Number: AM4119961 Exp. Date: 2029-04-28
View official government recall

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