Reported Mar 11, 2026 · Completed
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Esaote S.p.a.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ESAOTE S.P.A. · Sesto Fiorentino · Sesto Fiorentino, N/A · N/A
Is this the product you have?
Esaote Endocavity ultrasonic probeModel E 3-12REF 120000038
- Lot codes and dates
- UDI 0805604453891
- Serial Numbers
241700533C241700529C241700607C241700536C241700613C
- Amount recalled
- 5 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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