Z-1490-2026Class II

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

Name: Z-1490-2026 Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Creator: Esaote S.p.a.
Published: 2025-03-14
License: https://open.fda.gov/license/

Esaote S.p.A. / initiated 2025-03-14 / Completed / root cause: manufacturing process

FDA source

ESAOTE S.P.A. began a recall of Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 on 2025-03-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1490-2026
Classification: Class II
Status: Completed
Initiated: 2025-03-14
Posted: 2026-03-03
Recalling firm: Esaote S.p.A.
Product: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Product code: ITX Transducer, Ultrasonic, Diagnostic
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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."
Quantity in commerce: 5 units
Distribution: US: Nationwide distribution in the states of NC and TX.
Product codes and lots: UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1490-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1490-2026	Class II	Completed	Voluntary: Firm initiated	2026-03-11	2026-03-03

Product code ITX

K230179Class II6440 MyLabX90Esaote, S.p.A. / cleared 2023-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)