ESAOTE S.P.A. Recalls Endocavity Ultrasonic Probes Due to Potential Liquid Leakage

What Happened

ESAOTE S.P.A. has initiated a voluntary recall of specific Endocavity ultrasonic probes after identifying a potential structural weakness in the probe body. In a specific production batch, liquid may leak from the terminal part of the casing near the cable connection, potentially compromising the device’s integrity.

Which Products Are Affected

The recall involves the Esaote Endocavity ultrasonic probe, Model E 3-12 (REF 120000038). A total of five units are affected by this recall, distributed within the states of North Carolina and Texas.

Identification Details:

• UDI: 0805604453891
• Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C
• Recall Number: Z-1490-2026

What You Should Do

ESAOTE S.P.A. notified affected customers via letter starting in March 2025. Healthcare facilities and providers in possession of the specific serial numbers listed above should immediately follow the instructions provided in the firm’s notification letter regarding the inspection, use, or return of the affected probes. For further information, users should contact the recalling firm, ESAOTE S.P.A., at their Sesto Fiorentino, Italy headquarters or through their authorized U.S. representatives.

Why This Matters

This recall is classified as Class II by the FDA, meaning the use of the defective product may cause temporary or medically reversible adverse health consequences. The leakage of liquid into or out of the probe casing could pose risks during medical procedures.

Source

Information provided by the FDA.