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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