Drug recall
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
FDA recall event 98339 · Class II · ESAOTE S.P.A.
Key facts
| Event ID | 98339 |
|---|---|
| Recall numbers | Z-1490-2026 |
| Recalling firm | ESAOTE S.P.A. |
| Product type | Devices |
| Products | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Mar 14, 2025 |
| Report date | Mar 11, 2026 |
| City | Sesto Fiorentino |
| Country | Italy |
| FEI number | 3012981490 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: