TherMax Blood Warmer Unit — Class II medical device recall Z-0247-2020
Terminated recall by Baxter Healthcare Corporation, reported 2019-11-06, distributed nationwide. TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective
| Recall number | Z-0247-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2019-09-19 |
| Classified | 2019-10-29 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, DE, ES, FI, FR, GB, GR, IT, NL, NO, NZ, PL, PT, SE |
| Quantity | 504 units |
| UPC / GTIN / UDI-DI | 00085412639505 |
| Serial numbers | 100261, 100263, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100292, 100294, 100296, 100298, 100299, 100306, 100307, 100308, 100309, 100310, 100312 and 475 more |
Product
TherMax Blood Warmer Unit
Reason for recall
TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.
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-0247-2020. 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.