Z-1490-2026 Class II
FDA device recall Z-1490-2026 was initiated by ESAOTE S.P.A. on Mar 14, 2025 and is designated Class II. 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. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 11, 2026
- Initiation Date
- Mar 14, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
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.
Distribution Pattern
US: Nationwide distribution in the states of NC and TX.
Code Information
UDI 0805604453891, Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1490-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026