# FDA recall Z-0038-2026

> **ImaCor Inc.** · Class II · device recall initiated 2025-08-29.

## 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

- **Recall number:** Z-0038-2026
- **Recalling firm:** ImaCor Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-29
- **Report date:** 2025-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jericho, NY, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0038-2026. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0038-2026. Source: US FDA. Licensed CC0.

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