Reported Jan 1, 2025 · Ongoing
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
O&m Halyard, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: O&M HALYARD, INC. · 9120 Lockwood Blvd · Mechanicsville, VA · 23116-2015
Is this the product you have?
- O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable
- surgical mask Product Code47500
- Lot codes and dates
- UDI-DI20680651475002
- Lot NumberAM4119961 Exp
- Date2029-04-28
- Amount recalled
- 637 cases
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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