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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