FDAClass IIAugust 26, 2026

Blanketrol III recall

Blanketrol III, Model 233; Thermal regulating system.

Why was Blanketrol III recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277

Product
Blanketrol III, Model 233; Thermal regulating system.
Recalling firm
Gentherm Medical, LLC
Quantity
9714 units
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.
Recall date
August 26, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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