Medical device recalls Moderate risk

ESAOTE S.P.A. recalls Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

Recall date
March 14, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1490-2026
FDA classification
Class II
Brand / firm
ESAOTE S.P.A.
Sold / distributed
US: Nationwide distribution in the states of NC and TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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