Blanketrol II Hyper-Hypothermia System — Class II medical device recall Z-0418-2020
Terminated recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, reported 2019-11-27, distributed nationwide. Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Addit
| Recall number | Z-0418-2020 |
|---|---|
| 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 | 2019-07-02 |
| Classified | 2019-11-18 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2020-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BE, BH, BR, BS, CA, CL, CN, CO, CR, DE, EC, EG, ES, FR, GT, HK, ID, IL, IN, IT, JP, KE, KR, KW, LB, MA, MX, MY, NL, NP, NZ, OM, PA, PH, PK, QA, SA, SG, SV, TH, TR, TT, TW, VE, VN, ZA |
| Quantity | 3,726 |
| Model numbers | 222R, 222S |
Product
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Reason for recall
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
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-0418-2020. 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.