# FDA recall Z-1141-2026

> **Edan Diagnostics** · Class II · device recall initiated 2025-10-24.

## 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 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.

## 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.

## Key facts

- **Recall number:** Z-1141-2026
- **Recalling firm:** Edan Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-24
- **Report date:** 2026-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1141-2026

## Citation

> AI Analytics. FDA recall Z-1141-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1141-2026. Source: US FDA. Licensed CC0.

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