Norm-O-Temp model 111Z — Class II medical device recall Z-2355-2019
Terminated recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, reported 2019-09-11, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissu
| Recall number | Z-2355-2019 |
|---|---|
| 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 | 2019-06-20 |
| Classified | 2019-09-04 |
| Reported by FDA | 2019-09-11 |
| Terminated | 2020-06-09 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | AE, AT, AU, CA, CL, CN, CO, DE, EC, EG, GB, HK, ID, IL, JP, KR, KW, MA, MX, MY, NL, PA, PK, SG, TH, TR, TW, VE |
| Quantity | 674 |
| UPC / GTIN / UDI-DI | 10613031861532, 10613031861549 |
| Model numbers | 111Z, 86153, 86154 |
Product
Norm-O-Temp model 111Z
Reason for recall
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
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-2355-2019. 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.