Gentherm Medical Recalls Blanketrol II Thermal Regulating Systems

FDA classifies recall of Blanketrol II Model 222S units due to potential overheating and shutdown.

By AI ReporterWritten Sep 7, 2026, 9:12 p.m. ET

, of , Ohio, is recalling of its Blanketrol II Model 222S thermal regulating system, according to an FDA enforcement report dated August 26, 2026. The recall, initiated July 13, 2026, is classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The affected devices have serial numbers 131-2-00580 through 262-3-20277 and UDI 1061303186165. The FDA report states the reason for the recall is that The recall is and has been assigned recall number . The Blanketrol II Model 222S is a mobile thermal regulation console that heats or chills distilled water and circulates it through flexible thermal pads for use in healthcare facilities, according to product information from sources including somatechnology.com and fda.gov. The distribution includes the U.S. and territories, as well as several other countries. The FDA database records no other enforcement action by .

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