Recall MonitorHealth Products
Caputron Brain Premier tDCS and Brain Ultimate VNS
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: Caputron Brain Premier tDCS and Brain Ultimate VNS
Issue: Medical devices - Unauthorised device
What to do: Customers will be notified and provided with the option to request a refund or return of the product.
Audience: General public
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Brain Premier tDCS | Not applicable. | C-BPE1+ |
| Brain Ultimate VNS | Not applicable. | C-BU-VNS |
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