Class II

Medical Device Recall: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

ESAOTE S.P.A. · March 14, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

5 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1490-2026

Status: completed

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