Recall MonitorHealth Products
Vivos Guides
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Dental
Product: Vivos Guides
Issue: Medical devices - Unauthorised device
What to do: Contact the manufacturer if you require additional information.
Audience: General public
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0003 : GUID0003-KIDS-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0003 : GUID0003-KIDS-PIN |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-45-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-50-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-50-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-65-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0003 : GUID0003-KIDS-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0003 : GUID0003-VSTR-PUR |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-25-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-30-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-40-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-60-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-65-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-35-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0008 : GUID0008-PUR |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-30-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-35-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-35-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-40-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-60-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-40-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-50-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0003 : GUID0003-VSTR-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-25-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-30-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-40-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-50-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-70-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-55-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-55-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-70-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-70-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-35-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-45-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-25-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-55-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-65-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-45-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-70-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0008 : GUID0008-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0008 : GUID0008-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0003 : GUID0003-KIDS-PUR |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0003 : GUID0003-VSTR-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0003 : GUID0003-VSTR-PIN |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-35-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0004 : GUID0004-65-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0005 : GUID0005-45-CLE |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-30-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-45-BLU |
| Vivos Guides | More than 10 numbers, contact manufacturer. | GUID0006 : GUID0006-55-BLU |
Issue
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