HALYARD SURGICAL HOOD — Class III medical device recall Z-1461-2024
Ongoing recall by O&M HALYARD, INC., reported 2024-04-10, distributed nationwide. Product was mislabeled as a Surgical Cap at its dispenser level.
| Recall number | Z-1461-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | O&M HALYARD, INC., Mechanicsville, VA, United States |
| Recall initiated | 2024-02-20 |
| Classified | 2024-04-02 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20680651691105 |
| Lot numbers | CG22292XXX |
| Model numbers | 69110 |
Product
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Reason for recall
Product was mislabeled as a Surgical Cap at its dispenser level.
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-1461-2024. 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.