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 | Ongoing |
| Reason | Overheating of the 115V CPU board may cause the device to shut down. |
| Product | Blanketrol II Model 222S; Thermal regulating system. |
| Quantity | 182 units |
| Distribution | Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago. |
| Initiated | 2026-07-13 |
| Classified | 2026-08-14 |
| Recall number | Z-2968-2026 |
| 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-2968-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99478/
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