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U.S. Department of Health and Human Services

Class 2 Device Recall ClariTEE

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 Class 2 Device Recall ClariTEEsee related information
Date Initiated by FirmAugust 29, 2025
Date PostedOctober 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0038-2026
Recall Event ID 97505
510(K)NumberK220490 
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
ProductClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Code Information Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
Recalling Firm/
Manufacturer		 ImaCor Inc.
50 Jericho Tpke Ste 105
Jericho NY 11753-1014
For Additional Information ContactJennifer Kujawski
1-516-3930970
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionImaCor, 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.
Quantity in Commerce45 units
DistributionUS Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ITX
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