Blue Ash, OH, United States
Gentherm Medical, LLC recalls
3 recalls recorded since 2018, most recently on 13 July 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 July 2026
- Reason
- Overheating of the 115V CPU board may cause the device to shut down.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2968-2026, Z-2970-2026, Z-2969-2026
- Blanketrol II Model 222S; Thermal regulating system.
- Blanketrol III, Model 233; Thermal regulating system.
- Innercool Coolblue Console, Model STx; Thermal regulating system.
Terminated Class II Medical devices
- Recall started
- 22 November 2021
- Terminated
- 8 May 2023
- Reason
- This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0496-2022
- Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Terminated Class II Medical devices
- Recall started
- 17 June 2021
- Terminated
- 1 March 2023
- Reason
- There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.
- Distribution
- Worldwide distribution. US nationwide, including Puerto Rico; Argentina, Bangladesh, Chile, Colombia, France, Guatemala, Hungary, India, Indonesia, Israel, Italy, Nepal, Nigeria, Pakistan, Philippines, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Turk
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2092-2021
- Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.