Jericho, NY, United States
ImaCor Inc. recalls
2 recalls recorded since 2018, most recently on 29 August 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 29 August 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0038-2026
- ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Ongoing Class II Medical devices
- Recall started
- 16 September 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0231-2025
- ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.