MICRO-TEMP LT System — Class III medical device recall Z-2291-2019
Terminated recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, reported 2019-08-28, distributed nationwide. Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damag
| Recall number | Z-2291-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cincinnati Sub-Zero Products LLC, a Gentherm Company, Cincinnati, OH, United States |
| Recall initiated | 2019-07-19 |
| Classified | 2019-08-19 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2020-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CL, CO, GT, IL, JP, KR, NL, PL, SG |
| Quantity | 2,079 units |
| UPC / GTIN / UDI-DI | 10613031881165 |
| Serial numbers | 141-LT-02789 |
| Model numbers | 749 |
Product
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Reason for recall
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may 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-2291-2019. 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.