FDAClass IIMarch 11, 2026

Esaote Endocavity ultrasonic probe recall

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

Why was Esaote Endocavity ultrasonic probe recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Recalling firm
ESAOTE S.P.A.
Quantity
5 units
Distribution
US: Nationwide distribution in the states of NC and TX.
Recall date
March 11, 2026
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls