FDA Medical devices recall ·
ClariTEE Miniaturized TEE probe recall
- Recall number
- Z-0038-2026
- Date
- (initiated August 29, 2025)
- Company / brand
- ImaCor Inc.
50 Jericho Tpke Ste 105, Jericho, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 45 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
Distribution
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
States: Florida Georgia New Jersey Pennsylvania South Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0038-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.