Innercool Coolblue Console, Model STx; Thermal regulating system.
FDA Recall Z-2969-2026 · Posted 2026-08-14
Recalling FirmGentherm Medical, LLC
Recall StatusOpen, Classified
Product CodeDWJ
Date Initiated2026-07-13
Product Quantity46 units
Reason for Recall
Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.
Firm Action
Genthem issued an URGENT Medical Device Notice to its consignees on 7/17/2026 via email. The notice explained the issue, potential risk, and request the following:
"Interim Recommendations:
1. Based on the low probability of harm, and absence of reported harm, associated with this issue, users may continue to use the device. In an abundance of caution, it is recommended to have an alternative means of providing therapy available.
2. Users should review and follow the device Instructions for Use; users should routinely verify the device s function and patient s condition during use.
3. Ensure that all users are informed of the contents of this letter. If you have further distributed this product, please provide those accounts with a copy of this notice."
For questions or if you have experienced the described issue or a related adverse event, call Gentherm Medical Technical Support at 1-888-437-5608.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.