---
title: "EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a... — FDA record Z-1492-2022 | Is It on Recall"
description: "Product may be mislabeled."
url: https://isitonrecall.com/recall/fda-device-z-1492-2022-ekosonic-kit-106cm-12cm-tz-the-ekosonic-endovascular-device-is-packaged-as-a-kit-that-includes-both/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC c... — FDA record Z-1492-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Product may be mislabeled.
- **Classification**: Class II
- **Recalling firm**: Boston Scientific Corporation
- **Quantity**: 10 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1492-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1492-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Aug 10, 2022
- **Recall initiation date**: May 25, 2022
- **Center classification date**: Aug 1, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1492-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)