Recall Z-2968-2026
Gentherm Medical, LLC · initiated July 13, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Blanketrol II Model 222S; Thermal regulating system.
Codes / lots: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2968-2026
- Initiated
- July 13, 2026
- Posted by FDA
- August 14, 2026
- Product code
- DWJ – System, Thermal Regulating
- Quantity
- 182 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.
- Recalling firm
- Gentherm Medical, LLC, Blue Ash, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2969-2026 Class II | Innercool Coolblue Console, Model STx; Thermal regulating system.Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and… | 07/13/2026Open, Classified |
| Z-2970-2026 Class II | Blanketrol III, Model 233; Thermal regulating system.Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and… | 07/13/2026Open, Classified |