---
title: "Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. ... — FDA record Z-1250-2022 | Is It on Recall"
description: "Potential for the tip of the electrode to detach during use."
url: https://isitonrecall.com/recall/fda-device-z-1250-2022-regard-item-number-800214007-sterile-gs00367-gastro-bypass-spartanburg-conmed-catalog-no-60-5274-944/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/... — FDA record Z-1250-2022

Reported terminated

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 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**: Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
- **Reason**: Potential for the tip of the electrode to detach during use.
- **Classification**: Class II
- **Recalling firm**: ROi CPS LLC
- **Quantity**: 125 units
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1250-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1250-2022%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 | Catalog No. 60-5274-944; Item Number: 800214007; Model Number: GS00367G; UDI/DI: 10194717101024; Lot Numbers: 88207G (Exp. Date: 05/11/2023), 88396G (Exp. Date: 05/26/2023), 88472G (Exp. Date: 06/02/2023), 88965G (Exp. Date: 07/02/2023), 91105 (Exp. Date: 01/07/2024) |

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

## Distribution

Distributed to North Carolina.

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

- [North Carolina](https://isitonrecall.com/state/north-carolina/)

## Dates in the source

- **Report date**: Jun 15, 2022
- **Recall initiation date**: May 3, 2022
- **Center classification date**: Jun 8, 2022
- **Termination date**: May 31, 2024

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-1250-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [ROi CPS LLC records](https://isitonrecall.com/brand/roi-cps-llc/)