FDA recall Z-1490-2026

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

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

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