Health Canada — Medical Devices · Canada · 2025-08-07 · Type II
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Reported risk: This recall submission is due to a difference in classification of 1 types of devices; both were originally inputted as Class 1 but after an audit review, the devices are determined to be Class 2 through the audit inspection, and therefore the manufacturer is stopping sale of these device, the Vivos Guides and the Vivos Pex. Recall start date: June 9, 2025
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