FDA Medical devices recall ·
O&M Halyard Procedure Mask with SO SOFT* Earloops… recall
- Recall number
- Z-0728-2025
- Date
- (initiated November 8, 2024)
- Company / brand
- O&M Halyard, Inc.
9120 Lockwood Blvd, Mechanicsville, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 211 cases
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0728-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.