Z-2968-2026Class II

Blanketrol II Model 222S; Thermal regulating system

Name: Z-2968-2026 Blanketrol II Model 222S; Thermal regulating system
Creator: Gentherm Medical, LLC
Published: 2026-07-13
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2026-07-13 / Open, Classified / root cause: design

FDA source

Gentherm Medical, LLC began a recall of Blanketrol II Model 222S; Thermal regulating system on 2026-07-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2968-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-13
Posted: 2026-08-14
Recalling firm: Gentherm Medical, LLC
Product: Blanketrol II Model 222S; Thermal regulating system.
Product code: DWJ System, Thermal Regulating
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.
Root cause tag: design
FDA 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. 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.
Product codes and lots: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2968-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2968-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14
Z-2969-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14
Z-2970-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code DWJ

K110104Class IIBlanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. / cleared 2011-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)