FDAClass II · Medical device · Recall Z-2969-2026 · Recalled August 26, 2026

Innercool Coolblue Console recall — Gentherm Medical, LLC

Agency report date: August 26, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Innercool Coolblue Console
Company / brand: Gentherm Medical
Lot / serial / date codes: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
Distribution: 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.

Agency product description and boundaries

Innercool Coolblue Console, Model STx; Thermal regulating system.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Innercool Coolblue Console recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2969-2026
Brand: All Gentherm Medical recalls
Classification: Class II
Units affected: 46 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Innercool Coolblue Console recall status

Companies & origin

Recalling firm location: Blue Ash, OH, United States
Firm address: 12011 Mosteller Rd Fl 3, 45241-1528

Identifying details (verbatim from the notice)

Product codes / lots: UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
Distribution: 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.
Firm notified the public via: E-Mail
FDA event ID: 99478
Recall initiated: July 13, 2026
FDA classified: August 14, 2026
FDA report date: August 26, 2026

Other medical device recalls from around the same time

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Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall — Boston Scientific CorporationFDA · August 26, 2026
Boston Scientific ENROUTE Transcarotid Neuroprotection System recall — Boston Scientific CorporationFDA · August 26, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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