Recall Z-2969-2026 ยท DWJ System, Thermal Regulating
Gentherm Medical, LLC
Innercool Coolblue Console, Model STx; Thermal regulating system.
| Date | Aug 14, 2026 (initiated Jul 13, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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. E |
| Quantity | 46 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS Cincinnati Sub-Zero Products, Inc., Sep 20, 2010 |