FDA Device recall Z-0038-2026
ClariTEE Miniaturized TEE probe
- FDA Device
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of ClariTEE Miniaturized TEE probe by Imacor, citing production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice ver….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0038-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-29 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Imacor |
| Distribution | US |
Product
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Reason
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
Identifiers
| code_info | Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0038-2026%22
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