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Class IIOngoing

Gentherm Medical, LLC recalls 3 products

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Gentherm Medical, LLC
Reason
Overheating of the 115V CPU board may cause the device to shut down.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99478…

Products (3)

  1. Blanketrol II Model 222S; Thermal regulating system.

    Codes/lots: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277Quantity: 182 unitsRecall no. Z-2968-2026Class II

  2. Innercool Coolblue Console, Model STx; Thermal regulating system.

    Codes/lots: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277Quantity: 46 unitsRecall no. Z-2969-2026Class II

  3. Blanketrol III, Model 233; Thermal regulating system.

    Codes/lots: UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277Quantity: 9714 unitsRecall no. Z-2970-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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