ESAOTE S.P.A. recalls Esaote Endocavity ultrasonic probe

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.

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."

• FDA enforcement recordOfficial FDA database entry for Z-1490-2026
• FDA 510(k) clearance · K230179The device's official FDA premarket clearance record
• FDA device classification · ITXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ESAOTE S.P.A.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.