Z-2968-2026Class II

Gentherm Medical, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-08-26

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.

Firm state

Product quantity

182 units

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Product description

Blanketrol II Model 222S; Thermal regulating system.

Code / lot info

UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →