Gentherm Innercool Coolblue Console Recall Over CPU Board Overheating

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Gentherm Medical, LLC is recalling 46 units of the Innercool Coolblue Console, Model STx, due to potential overheating of the 115V CPU board causing device shutdown.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "Overheating of the 115V CPU board may cause the device to shut down.", 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, medical-device.

What Happened

Gentherm Medical, LLC is recalling the Innercool Coolblue Console, Model STx thermal regulating system because overheating of the 115V CPU board may cause the device to shut down.

Which Products Are Affected

The recall involves 46 units of the Innercool Coolblue Console, Model STx, distributed worldwide with UDI 1061303186165 and serial numbers 131-2-00580 through 262-3-20277. Distribution includes the United States nationwide, 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. The recall number is Z-2969-2026.

What You Should Do

Consumers should contact Gentherm Medical, LLC for further instructions regarding the recalled devices.

Why This Matters

The Class II recall addresses a device malfunction that could interrupt thermal regulation during use.

Source

FDA Recall Z-2969-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Elsewhere in the country: similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Questions & Answers

Questions readers often have about this FDA recall.

What is this FDA recall about?
Gentherm Medical, LLC is recalling 46 units of the Innercool Coolblue Console, Model STx, due to potential overheating of the 115V CPU board causing device shutdown.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "Overheating of the 115V CPU board may cause the device to shut down." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.