# FDA recall Z-1152-2026

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

## Product

Brand Name: EDAN  Product Name: Vital Signs Monitor  Model/Catalog Number: M3B  Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a hospital, hospital type facilities environment and intra-hospital moves.  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-1152-2026
- **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-1152-2026

## Citation

> AI Analytics. FDA recall Z-1152-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1152-2026. Source: US FDA. Licensed CC0.

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