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FDA · Medical devices ·

Blanketrol III, Model 233; Thermal regulating system. recall

Gentherm Medical, LLC recalled Blanketrol III, Model 233; Thermal regulating system. on August 26, 2026 because of overheating of the 115V CPU board may cause the device to shut down. It was sold nationwide.

Why it was recalled

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

What's recalled

Blanketrol III, Model 233; Thermal regulating system.

Quantity: 9714 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Gentherm Medical, LLC, Blue Ash, OH
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
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
Recall number
Z-2970-2026
Source
U.S. Food and Drug Administration

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