The Hemotherm 400CE 115v — Class II medical device recall Z-0654-2017
Terminated recall by Cincinnati Sub-Zero Products Inc, reported 2016-11-30, distributed in CA, FL, GA, MA, MN, NC, NJ, OH…. The device may not maintain water flow or temperature control.
| Recall number | Z-0654-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cincinnati Sub-Zero Products Inc, Cincinnati, OH, United States |
| Recall initiated | 2016-11-07 |
| Classified | 2016-11-22 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-02-22 |
| Distributed | CA, FL, GA, MA, MN, NC, NJ, OH, PA, SC |
| Quantity | 50 |
| Reason classes | temperature control |
Product
The Hemotherm 400CE 115v, containing power board p/n 39945
Reason for recall
The device may not maintain water flow or temperature control.
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-0654-2017. 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.