Edan Diagnostics recalls Brand Name: EDAN Product Name: Fetal & Maternal Monitor

Recalling company

Edan Diagnostics

Product

Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. 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

3518

Lot / codes

EDAN Model: F9 UDI-DI code: 06944413800434 Serial/Lot Numbers: 460430-M16105660001 460430-M16700280001 460475-M16605590001 460475-M16605590002 460475-M16605590003 460475-M16605590004 460475-M16806530001 460475-M16806530002 460476-M16B07550001 460476-M16B07550002 460476-M16B07550003 460476-M17402630001 460476-M17402630002 460476-M17402630003 460476-M17402630004 460476-M17402630005 460476-M17607650001 460476-M17607650002 460476-M17607650003 460476-M17607650004 460476-M17607650005 460476-M17607650006 460476-M17607650007 460476-M17607650008 460476-M17607650009 460476-M17607650010 460517-M16804200001 460688-M17A07770001 460688-M17A07770002 460688-M17A07770003 460723-M17904190001 460945-M18200660001 460945-M18200660002 460945-M18200660003 460945-M18200660004 460945-M18200660005 460945-M18200660006 460945-M18200660007 460945-M18200660008 460945-M18200660009 460945-M18200660010 460945-M18200660011 460945-M18200660012 460945-M18200660013 460945-M18200660014 460945-M18200660015 460945-M18200660016 460945-M18200660017 460945-M18200660018 460945-M18200660019 460945-M18200660020 460945-M18200660021 460945-M18200660022 460945-M18200660023 460945-M18200660024 460945-M18200660025 460945-M18200660026 460945-M18200660027 460945-M18200660028 460945-M18200660029 460945-M18200660030 460945-M18200660031 460945-M18200660032 460956-M18504390001 460956-M18504390002 460956-M18504390003 460956-M18504390004 460956-M18504390005 460956-M18504390006 460956-M18504390007 460956-M18504390008 460956-M185043900

Company location

San Diego, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-1141-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1141-2026 in the FDA Enforcement Report. Also see FDA recall press releases.