115 V Blanketrol II — Class II medical device recall Z-1679-2014
Terminated recall by Cincinnati Sub-Zero Products Inc, reported 2014-06-11. The incorrect voltage component was placed into the device during manufacturing. This may make the device unab
| Recall number | Z-1679-2014 |
|---|---|
| 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 | 2014-01-08 |
| Classified | 2014-06-02 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2014-06-06 |
| Countries outside the US | TW |
| Quantity | 7 units |
| Serial numbers | 133-2-00697, 133-2-00698, 133-2-00699, 133-2-00700, 133-2-00701, 133-2-00702, 86165 |
| Model numbers | 222S, 86165 |
Product
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Reason for recall
The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but
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-1679-2014. 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.