Gentherm Blanketrol II Model : Overheating Risk
Gentherm recalls Blanketrol II Model 222S thermal regulators due to overheating risk causing shutdowns. Affected units have specific serial numbers.
Lower-risk recall
Overheating of the 115V CPU board may cause the device to shut down.
What happened, in plain English
Gentherm is recalling its Blanketrol II Model 222S thermal regulating system because overheating may cause the device to shut down. This could disrupt medical care if the device is needed. Read more at govinfonow.com/recall/697885-gentherm-blanketrol-ii-model-overheating-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/697885-gentherm-blanketrol-ii-model-overheating-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2968-2026
Cite this page
“Gentherm Blanketrol II Model : Overheating Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697885-gentherm-blanketrol-ii-model-overheating-risk. Based on FDA recall #Z-2968-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2968-2026%22&limit=1).
Why it’s dangerous
The 115V CPU board overheating can cause the device to shut down unexpectedly. This might interrupt temperature control for medical patients.
Who’s affected
Patients using this medical device for temperature regulation are affected. Those with the specific serial numbers listed are most at risk.
How to tell if you have this one
Check for the model number 'Blanketrol II Model 222S' and serial numbers between 131-2-00580 and 262-3-20277.
- Brand
Gentherm- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2968-2026 | Blanketrol II Model 222S; Thermal regulating system.; UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277 | 182 units |
| Z-2969-2026 | Innercool Coolblue Console, Model STx; Thermal regulating system.; UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277 | 46 units |
| Z-2970-2026 | Blanketrol III, Model 233; Thermal regulating system.; UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277 | 9714 units |
What to do — step by step
Check Device Model
Verify the model number is Blanketrol II Model 222S.
Identify Serial Number
Look for serial numbers between 131-2-00580 and 262-3-20277.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device dangerous?
The device may shut down due to overheating, but this is not a risk of serious injury or death.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2968-2026 (July 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2968-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.