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Health Canada Medical devices

Caputron Brain Premier tDCS and Brain Ultimate VNS

Issued September 12, 2025
Issue
U.S.-based importer (Caputron) inadvertently sold and shipped tDCS and VNS devices made in China to customers in Canada through its e-commerce website. The manufacturer and importer do not have MDEL licenses, nor does the device have an MDL license. Upon notification from Health Canada, these Class II devices are being recalled. No functional defects are identified in these devices. Recall start date: August 21, 2025
Hazard description
Unauthorised device
Product
Product name
Caputron Brain Premier tDCS and Brain Ultimate VNS
Reference
ID
RA-78050