RecallRadar

FDA Device recall Z-2969-2026

Innercool Coolblue Console, Model STx

On 2026-08-26 the FDA classified a Class II recall of Innercool Coolblue Console, Model STx by Gentherm Medical, citing overheating of the 115V CPU board may cause the device to shut down.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2969-2026
ClassificationClass II
Statusongoing
Initiated2026-07-13
Published2026-08-26
Last updated2026-09-13 11:58 UTC
CompanyGentherm Medical
DistributionUS

Product

Innercool Coolblue Console, Model STx; Thermal regulating system.

Reason

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

Identifiers

code_infoUDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2969-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.