ClariTEE Miniaturized TEE probe. Model Number: CLT-010 recallZ-0038-2026 · ImaCor Inc. · initiated Aug 29, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ImaCor Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
ImaCor, Inc. notified consignees on 08/29/2025 via email. Consignees were instructed to Immediately discontinue use of the affected ClariTEE probes, quarantine all affected units in inventory, confirm receipt of this notice, return all affected units to ImaCor, and complete and return the response form.
Recall details
- Recall number
- Z-0038-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 29, 2025
- Posted by the FDA
- Oct 3, 2025
- Recalling firm
- ImaCor Inc.
- Quantity
- 45 units
- Product code
- ITX
- FDA submissions
- K220490
- Distribution
- US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Product description
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Code information (models, lots, serial numbers)
Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ClariTEEImacor Inc · Transducer, Ultrasonic, Diagnostic2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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