O&M Halyard Procedure Masks Recalled for Unmet Bioburden Testing Requirements
O&M HALYARD is recalling O&M Halyard Procedure Masks (Product Code 47117) nationwide because they do not meet bioburden testing requirements printed on the packaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Surgical masks are risk-of-harm medical devices; elevated bioburden could increase infection risk, but no injury has been documented.
Plain-English summary
O&M HALYARD, INC. is recalling O&M Halyard Procedure Masks with SO SOFT Earloops, Yellow (Product Code 47117) nationwide. The masks do not meet the bioburden testing requirements of EN 14683, a standard printed on the packaging. Lot Number AM4049121 (expiration date February 18, 2029) is affected, totaling 211 cases.
The EN 14683 standard is not required for masks sold in the United States. However, because this standard was printed on the product packaging, compliance with the standard became required. The masks failed to meet this stated requirement.
The recalled product
- Product
- O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
- Manufacturer
- O&M HALYARD, INC.
- Category
- Medical Device — Surgical Mask
- Hazard
- bioburden
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: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18
Distribution
Distributed nationwide across the United States.
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