# Major Recall Alert: Vivos Guides Recalled Due to Classification Discrepancy
The Vivos Guides, a dental device from the Vivos brand, has been officially recalled after an audit classified the device as a higher risk than initially reported. Originally listed as Class 1, the devices have now been reclassified as Class 2 medical devices. To comply with regulations and ensure consumer safety, manufacturers have stopped the sale of both the **Vivos Guides** and **Vivos Pex** effective **June 9, 2025**.
This change has significant implications for healthcare providers and patients using these devices. Here’s everything you need to know about this important recall.
## Why This Recall is Important
Medical device classifications determine the level of risk associated with their use. A **Class 1 device** represents the lowest risk, while **Class 2 devices** involve a moderate level of risk requiring additional safety scrutiny.
During an audit, the **Vivos Guides** and associated product, the **Vivos Pex**, were reclassified to Class 2. This discrepancy flagged the devices for tighter regulation, which ultimately led to the decision to halt their sale. The recall acts as a precautionary move to ensure products meet the new classification’s compliance standards and pose no harm to users.
### Key Details:
- **Product Affected**: Vivos Guides, Vivos Pex
- **Brand**: Vivos Guides
- **Recall Reason**: Classification has been upgraded to Class 2 due to moderate safety risks.
- **Recall Start Date**: June 9, 2025
- **Location**: Canada
If you are currently using these devices, it’s critical to understand the potential changes this could bring and follow the manufacturer’s recommendations.
## Details of the Recall
The recall was initiated following an extensive audit process that reviewed the risk profiles associated with the devices. As per Canadian safety regulations, Class 2 products must undergo stricter manufacturing and usage protocols. Since the devices were originally designed under Class 1 guidelines, their continued distribution without compliance with the Class 2 standards was deemed unsafe.
The manufacturer has voluntarily stopped the sale of **Vivos Guides** and **Vivos Pex** as corrective actions proceed. Consumers and healthcare providers are urged to cease usage and consult the official recall notice for further actions.
For the latest update and an official statement from the authorities, visit the Government of Canada’s Recall and Safety Alert page here: [Vivos Guides Recall](https://recalls-rappels.canada.ca/en/alert-recall/vivos-guides).
## What You Should Do
If you or your patients are currently using the Vivos Guides or Vivos Pex devices, here’s what you need to do:
- Stop using the devices immediately.
- Contact the manufacturer or your healthcare provider for guidance on alternative treatments or device replacements.
- Monitor the **Government of Canada Recall Database** for updates and safety notifications.
- Report any adverse effects associated with the devices to the **Health Canada MedEffect Program**.
Protecting your health and safety is paramount, so don’t hesitate to take these steps.
## Stay Safe – Get Instant Recall Alerts
Recalls like this highlight the importance of staying informed about the safety of medical devices and consumer products. Don’t miss vital updates that could impact your health or your loved ones.
**Download our app now** to receive instant recall notifications straight to your phone. Stay ahead with real-time alerts, immediate safety guidance, and peace of mind.
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For more information on the Vivos Guides recall, be sure to check the official Canadian recall announcement [here](https://recalls-rappels.canada.ca/en/alert-recall/vivos-guides). Stay informed. Stay protected.