EkoSonic Kit 106cm — Class II medical device recall Z-1492-2022
Ongoing recall by Boston Scientific Corporation, reported 2022-08-10, distributed in CA, CT, GA, IA, IL, IN, NY, OH…. Product may be mislabeled.
| Recall number | Z-1492-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2022-05-25 |
| Classified | 2022-08-01 |
| Reported by FDA | 2022-08-10 |
| Distributed | CA, CT, GA, IA, IL, IN, NY, OH, TX, WY |
| Quantity | 10 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00858593006134 |
| Lot numbers | 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230, 8035075231, 8035075232, 8035075233, 8035075234 |
Product
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Reason for recall
Product may be mislabeled.
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-1492-2022. 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.