Class II

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

O&M HALYARD, INC. · November 8, 2024

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

States Affected

NATIONWIDE

Quantity Affected

637 cases

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0729-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

O&M HALYARD, INC. Medical Device Recall: O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500 | SafeCheck