Class II — ESAOTE S.P.A.
| Recalling firm | ESAOTE S.P.A. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Completed |
| Reason | 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. |
| Product | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 |
| Quantity | 5 units |
| Distribution | US: Nationwide distribution in the states of NC and TX. |
| Initiated | 2025-03-14 |
| Classified | 2026-03-03 |
| Recall number | Z-1490-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ESAOTE S.P.A. (Z-1490-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98339/
Alerts for ESAOTE S.P.A.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.