ClariTEE Probe- Miniature transesophageal echo ultrasound probe for… — Class II medical device recall Z-0231-2025
Ongoing recall by ImaCor Inc., reported 2024-11-06, distributed in FL, GA, NJ, TN. Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could a
| Recall number | Z-0231-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ImaCor Inc., Jericho, NY, United States |
| Recall initiated | 2024-09-16 |
| Classified | 2024-10-25 |
| Reported by FDA | 2024-11-06 |
| Distributed | FL, GA, NJ, TN |
| Quantity | 73 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00861589000108 |
| Lot numbers | 20250509, 20250823 |
| Model numbers | CLT-010, CLT-010-1 |
Product
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Reason for recall
Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.
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-0231-2025. 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.