Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
O&M Halyard SOFT TOUCH II Surgical Mask Recalled by O&M HALYARD, INC. Due to Not meeting the bioburden testing requirements of EN...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact O&M HALYARD, INC. directly.
Affected Products
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Quantity: 637 cases
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About O&M HALYARD, INC.
O&M HALYARD, INC. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report