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FDA (Device enforcement)Recalled 2026-07-13class ii

Gentherm Medical, LLC: Blanketrol II Model 222S; Thermal regulating system.

Is my product affected?

Blanketrol II Model 222S; Thermal regulating system.

  • UPC 1061303186165

Check against the official notice below — it lists the full affected range.

What happened

Gentherm Medical, LLC is recalling 182 units of the Blanketrol II Model 222S thermal regulating system due to a hazard where overheating of the 115V CPU board may cause the device to shut down. The affected devices were distributed worldwide, including across the United States and its territories (Puerto Rico) and in Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago. The recalled units have serial numbers ranging from 131-2-00580 through 262-3-20277.

The recall record does not specify a remedy or any actions that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Overheating of the 115V CPU board may cause the device to shut down.

Details from the source

Reason for recall: Overheating of the 115V CPU board may cause the device to shut down. 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. Quantity: 182 units Lot/code info: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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