Class 2 Device Recall Blanketrol II HyperHypothermia Temperature Management System

• Date Initiated by Firm: July 13, 2026
• Date Posted: August 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2968-2026
• Recall Event ID: 99478
• 510(K)Number: K110104
• Product Classification: System, thermal regulating - Product Code DWJ
• Product: Blanketrol II Model 222S; Thermal regulating system.
• Code Information: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
• FEI Number: 1516825
• Recalling Firm/ Manufacturer: Gentherm Medical, LLC; 12011 Mosteller Rd Fl 3; Blue Ash OH 45241-1528
• Manufacturer 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: 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DWJ