ClariTEE Miniaturized TEE probe — Class II medical device recall Z-0038-2026
Ongoing recall by ImaCor Inc., reported 2025-10-15, distributed nationwide. Production assembly error resulting in the potential for reversed articulation, where moving the lever forward
| Recall number | Z-0038-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ImaCor Inc., Jericho, NY, United States |
| Recall initiated | 2025-08-29 |
| Classified | 2025-10-03 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Quantity | 45 units |
| UPC / GTIN / UDI-DI | 00861589000108 |
| Lot numbers | 20261209 |
| Model numbers | CLT-010 |
Product
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0038-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.