Hemotherm CE — Class II medical device recall Z-1825-2017
Terminated recall by Cincinnati Sub-Zero Products Inc, reported 2017-04-26, distributed in AL, AZ, CA, CO, FL, GA, IL, KY…. Improperly rated fuses were used in the manufacture of the device.
| Recall number | Z-1825-2017 |
|---|---|
| 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 | 2017-03-09 |
| Classified | 2017-04-15 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2017-12-18 |
| Distributed | AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI |
| Countries outside the US | CA, MX, TW |
| Quantity | 390 devices |
| Model numbers | 400CE |
Product
Hemotherm CE, model 400CE, Heater-Cooling Device
Reason for recall
Improperly rated fuses were used in the manufacture of the device.
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-1825-2017. 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.