Class II — 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 II |
| Status | Ongoing |
| Reason | Surgical drape packs may have open seals, which may compromise the sterility of the product. |
| Product | Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029 |
| Quantity | 1316 |
| Distribution | Worldwide - US Nationwide distribution in the states of GA, AL, PA and the countries of MX. |
| Initiated | 2025-07-17 |
| Classified | 2025-09-04 |
| Recall number | Z-2520-2025 |
| 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 II recall — O&M HALYARD INC (Z-2520-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97394/
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