FDAFDA recall Z-2970-2026 · Aug 26, 2026
Gentherm Medical, LLC: Blanketrol III recall
Recall found
Product
Blanketrol III, Model 233; Thermal regulating system.
Reason for recall
Overheating of the 115V CPU board may cause the device to shut down.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- 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
- 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.
- Recalling firm
- Gentherm Medical, LLC, Blue Ash, OH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-13
Source: openFDA enforcement record Z-2970-2026 · search recall number Z-2970-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.