Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: Recalled by Edan Diagnostics Due to As a result of receiving an FDA It...

Date: October 24, 2025
Company: Edan Diagnostics
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Edan Diagnostics directly.

Affected Products

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No

Quantity: 195

Why Was This Recalled?

As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Edan Diagnostics

Edan Diagnostics has 18 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report