Gentherm Medical recall: Blanketrol II Model 222S and 2 more products
Gentherm Medical, LLC is recalling Blanketrol II Model 222S and 2 more products because of a fire hazard – 182 units; 46 units; 9714 units. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 13, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Blanketrol II Model 222S and 2 more products |
| Brand | Gentherm Medical |
| Company | Gentherm Medical, LLC |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 13, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 182 units; 46 units; 9714 units |
| Recall ID | 99478 |
Recalled products (3)
- Blanketrol II Model 222S; Thermal regulating system.
- FDA recall number
- Z-2968-2026
- Codes, lots and dates
- UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
- Quantity
- 182 units
- Classification
- Class II
- Innercool Coolblue Console, Model STx; Thermal regulating system.
- FDA recall number
- Z-2969-2026
- Codes, lots and dates
- UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
- Quantity
- 46 units
- Classification
- Class II
- Blanketrol III, Model 233; Thermal regulating system.
- FDA recall number
- Z-2970-2026
- Codes, lots and dates
- UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277
- Quantity
- 9714 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99478
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Blue Ash, OH, United States
Why it was recalled
The problem: a fire hazard.
The reason the FDA lists: “Overheating of the 115V CPU board may cause the device to shut down.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99478, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Gentherm Medical Blanketrol II Model 222S recalled?
Yes. Gentherm Medical, LLC recalled it on July 13, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of a fire hazard. The reason given: Overheating of the 115V CPU board may cause the device to shut down.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.