Electri-Cool II Portable Cold Therapy Unit — Class II medical device recall Z-0496-2022
Terminated recall by Gentherm Medical, LLC, reported 2022-01-19, distributed nationwide. This recall has been initiated to provide a labeling update with revised instruction how to operate the unit w
| Recall number | Z-0496-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentherm Medical, LLC, Blue Ash, OH, United States |
| Recall initiated | 2021-11-22 |
| Classified | 2022-01-13 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2023-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CL, HK, KR |
| Quantity | 484 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10613031861938 |
| Model numbers | 767, 86193 |
Product
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Reason for recall
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
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-0496-2022. 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.