ImaCor Inc.: Device Recall

Recall #Z-0038-2026 · 08/29/2025

Class II: Risk

Recall Details

Recall Number: Z-0038-2026
Classification: Class II
Product Type: Device
Recalling Firm: ImaCor Inc.
Status: Ongoing
Date Initiated: 08/29/2025
Location: Jericho, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 45 units

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.

Product Description

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

Distribution Pattern

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

Other Recalls by ImaCor Inc.

Class II: Risk 09/16/2024

Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.

View all recalls by ImaCor Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.