Class II — ImaCor Inc.
| Recalling firm | ImaCor Inc |
|---|---|
| Registered facility | IMACOR, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH. |
| Quantity | 45 units |
| Distribution | US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia. |
| Initiated | 2025-08-29 |
| Classified | 2025-10-03 |
| Recall number | Z-0038-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ImaCor Inc. (Z-0038-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97505/
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