Class II — Gentherm Medical, LLC
| Recalling firm | Gentherm Medical LLC |
|---|---|
| Registered facility | Jiangmen Dacheng Medical Equipment Co., Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. |
| Product | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 |
| Quantity | 484 devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE. |
| Initiated | 2021-11-22 |
| Classified | 2022-01-13 |
| Terminated | 2023-05-08 |
| Recall number | Z-0496-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Gentherm Medical, LLC (Z-0496-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89193/
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