Edan Diagnostics: Device Recall

Recall #Z-1143-2026 · 10/24/2025

Class II: Risk

Recall Details

Recall Number
Z-1143-2026
Classification
Class II
Product Type
Device
Recalling Firm
Edan Diagnostics
Status
Ongoing
Date Initiated
10/24/2025
Location
San Diego, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11987

Reason for Recall

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.

Product Description

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.

Other Recalls by Edan Diagnostics

View all recalls by Edan Diagnostics →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.