FDAFDA · Food and drugs·Recall number Z-2968-2026
Blanketrol II Model 222S; Thermal regulating system.
Published August 26, 2026 · Recall initiated: July 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Overheating of the 115V CPU board may cause the device to shut down.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Gentherm Medical, LLC
- Distributor
- 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.
- Lot
- UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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