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Gentherm Medical, LLC recalls Blanketrol II Model 222S; Thermal regulating system.
Recalled August 26, 2026 · FDA recall Z-2968-2026 · Gentherm Medical
Hazard
Overheating of the 115V CPU board may cause the device to shut down. · FDA Class II
Units
182 units
Sold at
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.
Description
Overheating of the 115V CPU board may cause the device to shut down.
Product
Blanketrol II Model 222S; Thermal regulating system.
Manufacturer(s)
Gentherm Medical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →