Lower riskMedical device recall · FDA · Published November 8, 2024
O&M Halyard Procedure Mask with SO SOFT* Earloops: EU Bioburden Testing Not Met
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.
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📍Recalling firmO&M HALYARD, INC.9120 Lockwood Blvd · Mechanicsville, VA 23116-2015
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/53524-o-m-halyard-procedure-mask-with-so-soft-earloops-eu.
“O&M Halyard Procedure Mask with SO SOFT* Earloops: EU Bioburden Testing Not Met.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53524-o-m-halyard-procedure-mask-with-so-soft-earloops-eu. Based on FDA recall #Z-0728-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0728-2025%22&limit=1).
The FDA announced on November 8, 2024, that O&M Halyard is recalling its Procedure Mask with SO SOFT* Earloops due to failure to meet European bioburden testing requirements. The recall affects 211 cases distributed nationwide.
How to tell if you have it
Brand: O&M HALYARD
Product: O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask
Product Code: 47117
Lot Number: AM4049121
Expiration Date: 2029-02-18
The hazard
The masks do not meet the bioburden testing requirements of EN 14683, a standard required for masks sold in Europe. Compliance is necessary if this standard is printed on the packaging.
Context
GovInfoNow's records show O&M HALYARD INC has issued six other recalls since September 27, 2021. Recent brand recalls include a July 17, 2025 orthopedic pack recall for open seals and an April 13, 2026 nitrile glove recall for chemical permeation failure. Other recent recalls of similar products include Healthmark Mesh Tip Protectors (March 12, 2026), Altruan Clearest Strep-A Cassette Test (December 19, 2025), and Bisaf Strep A Self-Test (December 19, 2025).
How to tell if you have this one
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.
Brand
O&M HALYARD
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Nationwide
Recall number
Product, codes & lots
Quantity
Z-0728-2025
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117; UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18
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.
Official source: FDA Recall #Z-0728-2025 (November 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0728-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.