---
title: "DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03 — FDA record Z-0649-2023 | Is It on Recall"
description: "XXX"
url: https://isitonrecall.com/recall/fda-device-z-0649-2023-deroyal-endovascular-tracepack-ref-89-9350-03/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03 — FDA record Z-0649-2023

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 Nov 3, 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**: DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
- **Reason**: XXX
- **Classification**: Class II
- **Recalling firm**: DeRoyal Industries Inc
- **Quantity**: 495 kits
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0649-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0649-2023%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 | Lot Numbers: Lot 56225516 exp 6/1/2024; Lot 56395460 exp 6/1/2024; Lot 56620751 exp 10/1/2024; Lot 56780958 exp 10/1/2024; Lot 57190141 exp 10/1/2024; Lot 57754751 exp 1/1/2025 |

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

## Distribution

US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

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

- [Alabama](https://isitonrecall.com/state/alabama/)
- [Arizona](https://isitonrecall.com/state/arizona/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Dec 21, 2022
- **Recall initiation date**: Nov 3, 2022
- **Center classification date**: Dec 15, 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-0649-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [DeRoyal Industries Inc records](https://isitonrecall.com/brand/deroyal-industries-inc/)