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MEDICAL DEVICE RECALLMODERATE
Gentherm Thermal Regulating System
Gentherm recalls thermal regulating systems over CPU board overheating that may cause shutdown.
What to do
Stop using the affected device and contact Gentherm Medical for repair or replacement.
Why it was recalled
Gentherm Medical is recalling certain thermal regulating systems because overheating on 115V CPU boards may cause the device to shut down unexpectedly during patient care.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| Innercool Coolblue Console, Model STx; Thermal regulating system. | Z-2969-2026 | 1061303186165 |
| Blanketrol III, Model 233; Thermal regulating system. | Z-2970-2026 | 1061303186102, 1061303186107, 1061303186139, 1061303187107, 1061303187307 |
| Blanketrol II Model 222S; Thermal regulating system. | Z-2968-2026 | 1061303186165 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification