FDA Medical devices recall ·
Esaote Endocavity ultrasonic probe, Model E 3-12 recall
- Recall number
- Z-1490-2026
- Date
- (initiated March 14, 2025)
- Company / brand
- Esaote S.P.A.
Sesto Fiorentino, Sesto Fiorentino, N/A, Italy - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 5 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
Distribution
US: Nationwide distribution in the states of NC and TX.
States: North Carolina Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1490-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.