Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA Recall Z-1490-2026 · Posted 2026-03-03
Recalling FirmESAOTE S.P.A.
Recall StatusCompleted
Product CodeITX
Date Initiated2025-03-14
Product Quantity5 units
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.
Firm Action
Esaote issued a Field Safety Notice to its consignees on 3/14/2025 via FedEx. The notice explained the problem with the device, potential risk of use and requested the following: "Actions to be performed by the user
" If the operator detects the issue during the inspection, they must NOT use the probe and should contact Esaote's technical support.
" Please distribute this Safety Notice to all personnel involved within your organization and to all users of the device.
" If the device is no longer in your possession, please provide Esaote with the new owner's details or inform us about the current status of the device.
As a precautionary measure, and to complete the root cause analysis while improving our processes and customer service, Esaote will proceed with a voluntary precautionary recall. Our Technical Support Service will soon contact customers who own the affected units to arrange for the replacement of the probe."
Root Cause
Process control
Distribution Pattern
US: Nationwide distribution in the states of NC and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.