Gentherm Medical, LLC recalls Innercool Coolblue Console

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

Innercool Coolblue Console, Model STx; Thermal regulating system.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2969-2026
• FDA 510(k) clearance · K101589The device's official FDA premarket clearance record
• FDA device classification · DWJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.5900The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Gentherm Medical, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.