FDA recall Z-0038-2026

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2025-08-29

Report date

2025-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jericho, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0038-2026