Summary
The FDA issued a Class II for Blanketrol III, Model 233; Thermal regulating system. by Gentherm Medical, LLC. Reason: Overheating of the 115V CPU board may cause the device to shut down..
Details
Source
Device Recall
External ID
Z-2970-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
Blanketrol III, Model 233; Thermal regulating system.
Lot/Code Info: UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277
Quantity Affected: 9714 units
Reason for Recall
Overheating of the 115V CPU board may cause the device to shut down.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-13
Company
Blue Ash, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Gentherm Medical, LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Gentherm Medical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Gentherm Medical, LLC have FDA actions?
Gentherm Medical, LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2970-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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