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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 211
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.
Part of a larger recall action
This product is one of 2 recalled by O&M HALYARD, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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