Gentherm Medical Recalls Blanketrol II Model 222S Thermal Regulating System
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Gentherm Medical, LLC is recalling 182 units of Blanketrol II Model 222S devices due to potential overheating of the 115V CPU board causing shutdown.
FDA recall: what the record actually shows
This notice was issued by FDA on September 8, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Overheating of the 115V CPU board may cause the device to shut down.", distributed 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Gentherm Medical, LLC initiated a voluntary recall of the Blanketrol II Model 222S thermal regulating system because overheating of the 115V CPU board may cause the device to shut down.
Which Products Are Affected
Blanketrol II Model 222S; Thermal regulating system. 182 units distributed worldwide including US nationwide distribution in 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. UDI: 1061303186165. Serial Numbers: 131-2-00580 through 262-3-20277. Recall number Z-2968-2026. Class II recall initiated July 13, 2026.
What You Should Do
The recall was initiated voluntarily by the firm via E-mail. Affected users should contact Gentherm Medical, LLC for additional information regarding the recall.
Why This Matters
This Class II recall involves a device that may experience shutdown due to overheating of the CPU board.
Source
FDA recall Z-2968-2026, Gentherm Medical, LLC, Blue Ash, OH.
Original source: FDA Official Notice ↗
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