Gentherm Medical Recalls Blanketrol II Thermal Regulating Systems
Gentherm Medical is recalling 182 Blanketrol II Model 222S thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional failure (shutdown) without reported injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Gentherm Medical, LLC is recalling 182 units of the Blanketrol II Model 222S thermal regulating system. The recall is due to a potential defect where overheating of the 115V CPU board may cause the device to shut down.
The affected units were distributed worldwide, including in the United States, Puerto Rico, Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago. The specific units involved have UDI 1061303186165 and serial numbers ranging from 131-2-00580 through 262-3-20277.
Users should check their device serial numbers against the provided range. If the device is affected, they should stop using it and contact Gentherm Medical, LLC for instructions on repair or replacement.
The recalled product
- Product
- Blanketrol II Model 222S; Thermal regulating system.
- Manufacturer
- Gentherm Medical, LLC
- Affected units
- 182
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277
Distribution
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