The Recall Desk
ModerateFDA (Devices)·Z-0729-2025·Announced 2025-01-01

O&M Halyard Surgical Masks Recalled for Failing Bioburden Testing

O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves bioburden testing non-compliance, which is precautionary and driven by labeling compliance with a non-mandated European standard rather than detected contamination or actual harm.

Plain-English summary

O&M Halyard SOFT TOUCH II Surgical Masks, a disposable blue surgical mask (Product Code 47500), are being recalled. The affected masks were distributed nationwide in approximately 637 cases. The specific lot number involved is AM4119961, with an expiration date of April 28, 2029.

The recall was initiated because these masks do not meet the bioburden testing requirements of the EN 14683 standard. Although surgical masks sold in the United States are not required to meet this standard, O&M Halyard printed the standard on the packaging of these masks. When the standard is printed on packaging, compliance with it is required.

No illnesses or injuries have been reported in connection with this recall.

Consumers who have purchased this product should stop using the affected lot. For more information, contact O&M Halyard, Inc. or the U.S. Food and Drug Administration.

The recalled product

Product
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Manufacturer
O&M HALYARD, INC.
Category
Medical Device — Surgical Mask
Hazard
  • bioburden
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 20680651475002 Lot Number: AM4119961 Exp. Date: 2029-04-28

Distribution

Distributed nationwide across the United States.

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