Class III — O&M HALYARD, INC.
| Recalling firm | O & M Halyard, Inc. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Product was mislabeled as a Surgical Cap at its dispenser level. |
| Product | HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) |
| Quantity | 250 cases (75,000 pieces) |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada. |
| Initiated | 2024-02-20 |
| Classified | 2024-04-02 |
| Recall number | Z-1461-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — O&M HALYARD, INC. (Z-1461-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94182/
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