Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor

Recalling company

Edan Diagnostics

Product

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 24, 2025

Reported

Jan 28, 2026

Distribution

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.

Status

Ongoing

Quantity

379

Lot / codes

EDAN Model: iX10 UDI-DI code: 06944413815889 Serial/Lot Numbers: 262541-M24816120001 262541-M24A09820001 262541-M24B06240003 262541-M24B06240002 262541-M24B06240001 262541-M25110410016 262541-M25110420014 262541-M25110420008 262541-M25110420009 262541-M25110420024 262541-M25110420023 262541-M25110420025 262541-M25110420018 262541-M25110410001 262541-M25110410009 262541-M25110410003 262541-M25110410004 262541-M25110410011 262541-M25110410015 262541-M25110410020 262541-M25110410002 262541-M25110410012 262541-M25110410005 262541-M25110410013 262541-M25110410014 262541-M25110410007 262541-M25110410008 262541-M25110410017 262541-M25110410018 262541-M25110410019 262541-M25110410010 262541-M25110420011 262541-M25110410006 262541-M25110420007 262541-M25110420020 262541-M25110420013 262541-M25110420001 262541-M25110420019 262541-M25110420022 262541-M25110420003 262541-M25110420010 262541-M25110420015 262541-M25110420004 262541-M25110420016 262541-M25110420012 262541-M25110420005 262541-M25110420017 262541-M25110420021 262541-M25110420006 262541-M25110420002 269944-M25514090006 269944-M25514090002 269944-M25514090004 269944-M25514090008 269944-M25514090007 269944-M25514090001 269965-M25510270004 269965-M25510270003 269965-M25510270001 269944-M25514090009 269944-M25514090005 269944-M25514090010 269965-M25510270002 269965-M25510270005 269944-M25514090003 262541-M25514080006 262541-M25510240004 262541-M25510240010 262541-M25514080005 262541-M25514080004 262541-M25514080002 262541-M2551408

Company location

San Diego, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-1149-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1149-2026 in the FDA Enforcement Report. Also see FDA recall press releases.