---
title: "COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Sin... — FDA record Z-1578-2023 | Is It on Recall"
description: "Custom sheath Introducer contains incorrect needle size"
url: https://isitonrecall.com/recall/fda-device-z-1578-2023-cobra-os-custom-sheath-introducer-kit-4-french-ref-e01p2-sterile-eo-single-use-rx-only-5-units/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units — FDA record Z-1578-2023

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 Mar 21, 2023. 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**: COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
- **Reason**: Custom sheath Introducer contains incorrect needle size
- **Classification**: Class II
- **Recalling firm**: Merit Medical Systems, Inc.
- **Quantity**: 1186 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1578-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1578-2023%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 # H2122096S1; UDI-DI: (00)884450525197 |

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

## Distribution

US Distribution to state of: Minnesota

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

- [Minnesota](https://isitonrecall.com/state/minnesota/)

## Dates in the source

- **Report date**: May 17, 2023
- **Recall initiation date**: Mar 21, 2023
- **Center classification date**: May 10, 2023

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-1578-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Merit Medical Systems, Inc. records](https://isitonrecall.com/brand/merit-medical-systems-inc/)