Recall Z-2969-2026— Gentherm Medical, LLC

Name: FDA recall Z-2969-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-13

Class II · Ongoing

Class II FDA medical device recall by Gentherm Medical, LLC, initiated 2026-07-13. It names one FDA 510(k) clearance: K101589. Product: Innercool Coolblue Console, Model STx; Thermal regulating system.. Reason: Overheating of the 115V CPU board may cause the device to shut down..

Recalling firm: Gentherm Medical, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-07-13
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K101589 — BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMSCincinnati Sub-Zero Products, Inc.·cleared 2010-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Innercool Coolblue Console, Model STx; Thermal regulating system.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.