⬅ Back to All Recalls

EZCam Intraoral Camera Recall Due to Importation and sale of an unlicensed cl...

# Major Recall Alert: EZCam Intraoral Camera Recalled Due to Importation and Sale of an Unlicensed Class II Medical Device

On **March 1, 2025**, health authorities issued a crucial recall for the **EZCam Intraoral Camera**, citing concerns over the importation and sale of an **unlicensed class II medical device**. Distributed by **Vatech America**, the product was **misclassified as a class I medical device**. This regulatory oversight raises important safety concerns for dental practitioners and patients. If you own or use the EZCam Intraoral Camera, here’s everything you need to know about the recall.

![EZCam Intraoral Camera Recall](https://myrecalls.app/images/products/28186_1741371990.jpg)

---

## Why This Recall is Important

Proper licensing and classification of medical devices play a critical role in patient safety. The **EZCam Intraoral Camera** was inaccurately classified by **Vatech America** as a **class I medical device**—reserved for low-risk devices like tongue depressors or examination gloves. However, the camera's actual classification as a **class II medical device** places it in a higher risk category, requiring stricter regulatory oversight.

Key concerns about the misclassification include:

- **Lack of proper compliance** with Health Canada's regulations for class II medical devices.
- **Potential risks** to patients due to the absence of appropriate testing and monitoring requirements.
- **Possible legal and liability issues** for dental clinics using the product without knowing its true classification.

Health Canada has taken proactive steps to limit the potential impact of this oversight by initiating the **recall on March 1, 2025**.

---

## Details of the Recall

Here’s an overview of the essential details about the EZCam Intraoral Camera recall:

- **Product Name:** EZCam Intraoral Camera
- **Brand:** EZCam
- **Distributor:** Vatech America
- **Recall Date:** March 1, 2025
- **Reason for Recall:** Importation and sale of **unlicensed class II medical devices** due to misclassification as class I medical devices.
- **Affected Market:** Canada

For further verification, consult the official announcement [here](https://recalls-rappels.canada.ca/en/alert-recall/ezcam-intraoral-camera).

---

## What You Should Do

If you or your dental clinic owns or operates an EZCam Intraoral Camera, follow these steps:

1. **Stop using the device immediately** to mitigate potential risks to patients and staff.
2. **Contact the distributor (Vatech America)** for instructions on how to return the product or obtain further guidance.
3. **Report any incidents** involving the use of the EZCam Intraoral Camera to Health Canada by accessing their incident reporting system.
4. **Check your inventory for similar devices** to ensure compliance with class II regulations.

It’s crucial to act swiftly to avoid potential complications. If you are uncertain about this or similar devices’ classifications in your practice, consult Health Canada’s guidelines on medical device licensing for clarity.

---

## Stay Safe – Get Instant Recall Alerts

Recalls like this one highlight the importance of staying informed about the safety and compliance of the products you use daily. Avoid missing critical alerts by downloading the **MyRecalls app**. With real-time updates and user-friendly notifications, you can ensure that you’re always in the loop when it comes to product safety.

### Download the MyRecalls App Now!
Stay fully informed and protect your patients, staff, and loved ones from risks linked to recalls. **Get free updates today!**

---

The **EZCam Intraoral Camera recall** serves as a reminder for medical professionals to prioritize safety and compliance. Always verify the licensing of medical devices to reduce health risks and safeguard your practice from regulatory issues.

For more information, visit the official [recall notice](https://recalls-rappels.canada.ca/en/alert-recall/ezcam-intraoral-camera).

⬅ Back to All Recalls