Class II

Medical Device Recall: ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

ImaCor Inc. · August 29, 2025

Reason for Recall

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.

Distribution

US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.

States Affected

NATIONWIDE

Quantity Affected

45 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0038-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

ImaCor Inc. Medical Device Recall: ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH. | SafeCheck