# FDA recall Z-1490-2026

> **ESAOTE S.P.A.** · Class II · device recall initiated 2025-03-14.

## Product

Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

## Reason for recall

A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.

## Distribution

US: Nationwide distribution in the states of NC and TX.

## Key facts

- **Recall number:** Z-1490-2026
- **Recalling firm:** ESAOTE S.P.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2025-03-14
- **Report date:** 2026-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sesto Fiorentino, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2026

## Citation

> AI Analytics. FDA recall Z-1490-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1490-2026. Source: US FDA. Licensed CC0.

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