TherMax Blood Warmer Unit-US — Class II medical device recall Z-2439-2025
Ongoing recall by VANTIVE US HEALTHCARE LLC, reported 2025-09-03. Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to diffi
| Recall number | Z-2439-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | VANTIVE US HEALTHCARE LLC, Deerfield, IL, United States |
| Recall initiated | 2025-07-28 |
| Classified | 2025-08-26 |
| Reported by FDA | 2025-09-03 |
| Quantity | 7,432 units |
| UPC / GTIN / UDI-DI | 07332414124731 |
Product
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Reason for recall
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
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-2439-2025. 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.