Esaote Endocavity ultrasonic probe — Class II medical device recall Z-1490-2026
Completed recall by ESAOTE S.P.A., reported 2026-03-11, distributed nationwide. A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid ma
| Recall number | Z-1490-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | ESAOTE S.P.A., Sesto Fiorentino, N/A, Italy |
| Recall initiated | 2025-03-14 |
| Classified | 2026-03-03 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Reason classes | packaging |
| Serial numbers | 241700529C, 241700533C, 241700536C, 241700607C, 241700613C |
| Model numbers | 120000038, 3-12 |
Product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1490-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.