Official recall record
Caputron Brain Premier tDCS and Brain Ultimate VNS
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-09-12
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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