Health product recall

Vivos Guides

Last updated

Summary

Product
Vivos Guides
Issue
Medical devices - Unauthorised device
What to do

Contact the manufacturer if you require additional information. 

Affected 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
Vivos Therapeutics, Inc.
7921 Southpark Plaza, Littleton, Colorado, United States, 80120
Published by
Health Canada
Audience
General public
Recall class
Type II
Identification number
RA-77812

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