FDA Device recall Z-1490-2026
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
- FDA Device
- Class II
- completed
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 by Esaote S P A, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1490-2026 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-03-14 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Esaote S P A |
| Distribution | US |
Product
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
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.
Identifiers
| code_info | UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1490-2026%22
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