Reported Oct 15, 2025 · Ongoing
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile…
ImaCor Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ImaCor Inc. · 50 Jericho Tpke Ste 105 · Jericho, NY · 11753-1014
Is this the product you have?
- ClariTEE Miniaturized TEE probe
- Model NumberCLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH
- Lot codes and dates
Model CLT-010UDI-DI 00861589000108
- Lot number20261209
- Amount recalled
- 45 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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