ImaCor Inc.: Medical Device Recall in 2025 - (Recall #: Z-0038-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 29, 2025

Date Posted: October 15, 2025

Recall Number: Z-0038-2026

Event ID: 97505

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.

Status: Ongoing

Product Quantity: 45 units

Code Information:

Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated