Class II U.S. Food and Drug Administration

Gentherm Medical, LLC Innercool Coolblue Console, Model STx recall: Overheating of the 115V CPU board may cause the device to shut down

Recall published 2 months ago

Overheating of the 115V CPU board may cause the device to shut down.

The hazard: Fire or burn hazard

The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

What the notice says: Overheating of the 115V CPU board may cause the device to shut down.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2969-2026
Published
August 26, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Gentherm Medical, LLC
Product type
Medical devices
Units affected
46 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
UPC codes
1061303186165

Products covered by this recall

Innercool Coolblue Console, Model STx; Thermal regulating system.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 1061303186165

Serial number

On the rating plate, often next to the date of manufacture.

  • 131-2-00580
  • 262-3-20277 — 46 unit

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Gentherm Medical, LLC — The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Do not leave it charging overnight or while the house is empty while you wait for the remedy.
  3. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.
  4. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.

Company contact: Gentherm Medical, LLC — 12011 Mosteller Rd Fl 3, Blue Ash, OH, 45241-1528

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Gentherm Medical, LLC medical devices recalled?

Overheating of the 115V CPU board may cause the device to shut down. Overheating of the 115V CPU board may cause the device to shut down.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 1061303186165. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls