FDA-Device2025-01-01Class II
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
O&M HALYARD, INC.
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.
Sold states
Nationwide
Affected count
637 cases
Manufactured in
9120 Lockwood Blvd, Mechanicsville, VA, United States
Products
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0729-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief