FDA Medical devices recall ·
Innercool Coolblue Console, Model STx recall
- Recall number
- Z-2969-2026
- Date
- (initiated July 13, 2026)
- Company / brand
- Gentherm Medical, LLC
12011 Mosteller Rd Fl 3, Blue Ash, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 46 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Innercool Coolblue Console, Model STx; Thermal regulating system.
Why was it recalled?
Overheating of the 115V CPU board may cause the device to shut down.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
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.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2969-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.