Hemotherm 400CE — Class II medical device recall Z-0063-2019
Terminated recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, reported 2018-10-10, distributed nationwide. Potential for membrane (control panel) switch errors leading to an inability of the device to change control s
| Recall number | Z-0063-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH, United States |
| Recall initiated | 2018-09-04 |
| Classified | 2018-10-03 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2019-05-23 |
| Distributed | Nationwide (US) |
| Quantity | 270 units |
| UPC / GTIN / UDI-DI | 10613031860221 |
| Model numbers | 86022, 86023 |
Product
Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Reason for recall
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
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-0063-2019. 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.