Class II

Medical Device Recall: Innercool Coolblue Console, Model STx; Thermal regulating system.

Gentherm Medical, LLC · July 13, 2026

Reason for Recall

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

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.

States Affected

NATIONWIDE

Quantity Affected

46 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2969-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.