O&M Halyard SOFT TOUCH II Surgical Mask — Class II medical device recall Z-0729-2025
Ongoing recall by O&M HALYARD, INC., reported 2025-01-01, distributed nationwide. Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold
| Recall number | Z-0729-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | O&M HALYARD, INC., Mechanicsville, VA, United States |
| Recall initiated | 2024-11-08 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Quantity | 637 cases |
| UPC / GTIN / UDI-DI | 20680651475002 |
| Lot numbers | AM4119961 |
| Expiration dates | 2029-04-28 |
Product
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0729-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.