FDA recall, , Moderate risk
Esaote Endocavity Ultrasonic Probe E 3-12
The Esaote Endocavity ultrasonic probe may leak liquid from its casing near the cable.
Summary by Recall Canary from the FDA notice
What happened
ESAOTE S.P.A., of Sesto Fiorentino, Italy, recalled 5 units of its Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038. The agency stated that a potential weakness in the probe body may allow liquid to leak from the terminal part of the casing near the cable. The recall began on March 14, 2025, and was added to the FDA's Enforcement Report on March 3, 2026.
The product was distributed nationwide in the states of North Carolina and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Esaote Endocavity ultrasonic probe
- Model number
- E 3-12
- REF 120000038
- UDI-DI
- 0805604453891
Recall details
- Company began the recall
- Sold in
US: Nationwide distribution in the states of North Carolina and Texas.
- Company
- ESAOTE S.P.A.Sesto Fiorentino, Italy
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98339
- Recall number
- Z-1490-2026
- Quantity recalled
- 5 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
