FDA recall Z-0728-2025

Product

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

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2024-11-08

Report date

2025-01-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mechanicsville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0728-2025