HAWK Advanced Hypothermia Management Set — Class II medical device recall Z-3182-2024
Ongoing recall by Safeguard US Operating LLC, reported 2024-09-25, distributed nationwide. Incorrect expiration date.
| Recall number | Z-3182-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Safeguard US Operating LLC, Harrisburg, NC, United States |
| Recall initiated | 2024-08-27 |
| Classified | 2024-09-19 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 408 units |
| Reason classes | labeling |
| Lot numbers | PBO0003797, PBO0003811, PBO0004032, PBO0004315, PBO0004580 |
| Model numbers | 59-320 |
Product
HAWK Advanced Hypothermia Management Set, Item Number: 59-320
Reason for recall
Incorrect expiration date.
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-3182-2024. 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.