ESAOTE S.P.A.: Medical Device Recall in 2026 - (Recall #: Z-1490-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 14, 2025

Date Posted: March 11, 2026

Recall Number: Z-1490-2026

Event ID: 98339

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.

Status: Completed

Product Quantity: 5 units

Code Information:

UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.

Distribution Pattern:

US: Nationwide distribution in the states of NC and TX.

Voluntary or Mandated:

Voluntary: Firm initiated