# FDA recall Z-0231-2025

> **ImaCor Inc.** · Class II · device recall initiated 2024-09-16.

## Product

ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms.  Model/Catalog Number: CLT-010, CLT-010-1

## Reason for recall

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.

## Distribution

FL ,GA,  NJ, TN

## Key facts

- **Recall number:** Z-0231-2025
- **Recalling firm:** ImaCor Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-16
- **Report date:** 2024-11-06

- **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-0231-2025

## Citation

> AI Analytics. FDA recall Z-0231-2025. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0231-2025. Source: US FDA. Licensed CC0.

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