FDA recall Z-2969-2026

Gentherm Medical, LLC · Class II · device

Product

Innercool Coolblue Console, Model STx; Thermal regulating system.

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.

Key facts

Status
Ongoing
Initiation date
2026-07-13
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Blue Ash, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2969-2026