FDA Device recall Z-0728-2025
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117 by O And M Halyard, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0728-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-08 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | O And M Halyard |
| Distribution | US |
Product
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Reason
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.
Identifiers
| code_info | UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by O And M Halyard
- Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
FDA Device · Class II · 2026-06-03 · O And M Halyard - Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029
FDA Device · Class II · 2025-09-10 · O And M Halyard - Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Co…
FDA Device · Class II · 2025-01-29 · O And M Halyard - O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
FDA Device · Class II · 2025-01-01 · O And M Halyard - HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
FDA Device · Class III · 2024-04-10 · O And M Halyard
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0728-2025%22
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