O&M Halyard recalls yellow disposable surgical masks with SO SOFT* earloops (Product Code 47117) due to failing EU bioburden testing standards. Masks sold in the U.S. don't require this standard but must comply if labeled.
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 yellow disposable surgical masks with SO SOFT* earloops because they failed EU bioburden testing. This means the masks may not meet European safety standards for microbial contamination, though U.S. masks don't require this test. The recall is for specific product codes sold with certain lot numbers.
The masks failed EU bioburden testing, which measures microbial contamination. While U.S. masks don't require this standard, if the label states compliance, it must be met. This could mean the masks might not be as safe as intended for medical use in certain contexts.
Users of O&M Halyard Procedure Masks with SO SOFT* Earloops (Product Code 47117) are affected. Healthcare workers and others using these masks for medical purposes may be at risk if the masks fail to meet EU bioburden standards.
Check for the Product Code 47117 on the packaging. The masks have SO SOFT* earloops and are yellow-disposable surgical masks. They were sold with Lot Number AM4049121 and expire February 2029.
Look for Product Code 47117, SO SOFT* earloops, and yellow color on the mask packaging.
No, the recall states these masks failed EU bioburden testing. U.S. masks don't require this standard, but if labeled as compliant, they must meet it.
The masks did not meet EU bioburden testing requirements for masks sold in Europe. However, U.S. masks are not required to meet this standard unless labeled as compliant.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send O&M HALYARD to request your refund or repair — edit it as you like.
Subject: Recall Z-0728-2025 — O&M HALYARD O&M HALYARD Hello, I own a O&M HALYARD that is covered by recall Z-0728-2025 from O&M HALYARD. 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.
