Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor

Recalling company

Edan Diagnostics

Product

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. 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

13934

Lot / codes

EDAN Model: M3 UDI-DI code: 06944413800618 Serial/Lot Number: 302050-M16200560001 302050-M16200560002 302089-M16203830017 302089-M16203830006 302089-M16203830020 302127-M15B11010006 302127-M16203840001 302127-M16203840002 302127-M16203840003 302127-M16203840004 302127-M16203840005 302127-M16203840006 302127-M16203840007 302127-M16203840008 302127-M16203840009 302127-M16203840010 302127-M16203840011 302127-M16203840012 302127-M16203840013 302127-M16203840014 302089-M16203830019 302089-M16203830018 302089-M16203830016 302089-M16203830015 302089-M16203830014 302089-M16203830013 302089-M16203830012 302089-M16203830011 302089-M16203830010 302089-M16203830008 302089-M16203830007 302089-M16203830005 302089-M16203830004 302089-M16203830009 302050-M16203850007 302089-M16203830003 302050-M16203850001 302089-M16203830002 302089-M16203830001 302050-M16203850010 302050-M16203850009 302050-M16203850008 302050-M16203850002 302050-M16203850006 302050-M16203850005 302050-M16203850004 302050-M16203850003 302050-M16407160008 302050-M16407160007 302050-M16407160006 302050-M16407160005 302050-M16407160004 302050-M16407160003 302050-M16407160002 302050-M16407160001 302050-M16407160009 302050-M16407160010 302127-M16407150005 302127-M16407150004 302127-M16407150003 302127-M16407150002 302127-M16407150001 302089-M16407140001 302089-M16407140002 302089-M16407140004 302089-M16407140005 302089-M16407140006 302089-M16407140007 302089-M16407140008 302089-M16407140009 302089-M16407140010 302089-M1640714000

Company location

San Diego, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-1142-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1142-2026 in the FDA Enforcement Report. Also see FDA recall press releases.