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CLASS II · ModerateFDA

Gentherm Medical, LLC recalls Blanketrol III

📅 Jul 13, 2026 · 📍 Nationwide
Recalling company
Gentherm Medical, LLC
Product
Blanketrol III, Model 233; Thermal regulating system.
Reason
Overheating of the 115V CPU board may cause the device to shut down.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Jul 13, 2026
Reported
Aug 26, 2026
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.
Status
Ongoing
Quantity
9714 units
Lot / codes
UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277
Company location
Blue Ash, OH
Recall type
Voluntary: Firm initiated
Recall number
Z-2970-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2970-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.