CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
Innercool Coolblue Console recalled by Gentherm Medical
Gentherm Medical is recalling Innercool Coolblue Console, distributed nationwide in the US. The recall was initiated on 13 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2969-2026
- FDA event ID
- 99478
- Recalling firm
- Gentherm Medical, Blue Ash, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Jul 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +32 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Overheating of the 115V CPU board may cause the device to shut down.
Product as listed by the FDA
Innercool Coolblue Console, Model STx; Thermal regulating system.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Overheating of the 115V CPU board may cause the device to shut down.
Which lots are affected?
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99478This product is part of a recall event; the main page for the event is Blanketrol II recalled by Gentherm Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Blanketrol II recalled by Gentherm Medical | Gentherm Medical | Other | Nationwide | |
| CLASS II | Blanketrol III recalled by Gentherm Medical | Gentherm Medical | Other | Nationwide |
More recalls from Gentherm Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Blanketrol III recalled by Gentherm Medical | Gentherm Medical | Other | Nationwide |
| Device | CLASS II | Blanketrol II recalled by Gentherm Medical | Gentherm Medical | Other | Nationwide |
| Device | CLASS II | Electri-Cool II Portable Cold Therapy Unit recalled by Gentherm Medical | Gentherm Medical | Other | Nationwide |
| Device | CLASS II | Hemotherm CE Dual Reservoir Cooler/Heater recalled by Gentherm Medical | Gentherm Medical | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |