O&M Halyard recalls blue disposable surgical masks (Product Code 475: 47500) that failed EU bioburden testing. U.S. masks don't need this standard, but if printed on packaging, compliance is required.
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.
O&M Halyard is recalling blue disposable surgical masks (Product Code 47500) that didn't meet EU bioburden testing standards. This doesn't affect U.S. masks, which don't require this standard, but masks with printed compliance labels must meet it.
The masks failed EU bioburden testing, which measures microbial contamination. U.S. masks don't need this standard, but if the standard is printed on packaging, compliance is required. This means masks with printed labels might not be safe for medical use.
Surgical mask users in the U.S. who bought the blue disposable O&M Halyard SOFT TOUCH II masks with Product Code 47500. Those with masks that have the EU bioburden standard printed on packaging are at higher risk.
Check for the blue color, Product Code 47500, and the expiration date of April 28, 2029. The mask may have the EU bioburden standard printed on the packaging.
If the mask has the EU bioburden standard printed on the packaging, it may not meet safety requirements.
No, U.S. masks are not required to meet EU bioburden testing standards. However, if the standard is printed on packaging, compliance is required.
Check if the mask has the EU bioburden standard printed on the packaging. If it does, contact O&M Halyard for guidance.
The masks failed EU bioburden testing, so they may not be safe for medical use if the standard is printed on packaging.
We’ve drafted a message you can send O&M Haly: a short, human brand name for headings (e.g. to request your refund or repair — edit it as you like.
Subject: Recall Z-0729-2025 — O&M Haly: a short, human brand name for headings (e.g. O&M Haly: a short, human brand name for head Hello, I own a O&M Haly: a short, human brand name for headings (e.g. that is covered by recall Z-0729-2025 from O&M Haly: a short, human brand name for headings (e.g.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
