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Home › FDA recalls › Esaote Endocavity ultrasonic probe
CLASS II · ModerateFDA

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

📅 Mar 14, 2025 · 📍 Nationwide
Recalling company
ESAOTE S.P.A.
Product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Reason
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 14, 2025
Reported
Mar 11, 2026
Distribution
US: Nationwide distribution in the states of NC and TX.
Status
Completed
Quantity
5 units
Lot / codes
UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
Company location
Sesto Fiorentino, N/A
Recall type
Voluntary: Firm initiated
Recall number
Z-1490-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1490-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.