ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultra
Summary
The FDA issued a Class II for ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniatur by ImaCor Inc.. Reason: Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather.
Details
Source
Device Recall
External ID
Z-0038-2026
Action Date
2025-10-15
Status
Ongoing
Category
device
Product Description
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Lot/Code Info: Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
Quantity Affected: 45 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-29
Company
Jericho, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ImaCor Inc. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ImaCor Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ImaCor Inc. have FDA actions?
ImaCor Inc. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0038-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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