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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

ClariTEE Miniaturized TEE Probes Recalled for Reversed Control Defect

Agency Publication Date: October 3, 2025
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Summary

ImaCor Inc. is recalling 45 units of the ClariTEE Miniaturized TEE probe (Model CLT-010) due to a manufacturing error that causes the device's tip to move in the opposite direction of the control lever. During medical procedures, moving the lever forward causes the tip to tilt forward when it should tilt backward, and vice versa. Healthcare providers should stop using affected units and contact the manufacturer to arrange for a replacement or repair.

Risk

The reversed movement of the probe tip can lead to incorrect placement or accidental tissue damage during ultrasound procedures. This defect poses a risk of internal injury if a clinician unintentionally steers the probe against delicate structures while believing they are moving it away.

What You Should Do

  1. The recalled products are ClariTEE Miniaturized TEE probes, Model Number CLT-010, belonging to Lot 20261209.
  2. Check the device label or packaging for Lot number 20261209 and UDI-DI 00861589000108 to determine if your unit is affected.
  3. Stop using the recalled device immediately to prevent patient injury.
  4. Contact ImaCor Inc. or your equipment distributor to arrange for the return, replacement, or correction of the affected probe.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or to report concerns.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ClariTEE Miniaturized TEE probe
Model / REF:
CLT-010
Lot Numbers:
20261209
UDI:
00861589000108

Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97505
Status: Active
Manufacturer: ImaCor Inc.
Sold By: ImaCor Inc.; Medical equipment distributors
Manufactured In: United States
Units Affected: 45 units
Distributed To: South Carolina, New Jersey, Pennsylvania, Florida, Georgia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.