# FDA recall Z-1250-2022

> **ROi CPS LLC** · Class II · device recall initiated 2022-05-03.

## Product

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG.     CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

## Reason for recall

Potential for the tip of the electrode to detach during use.

## Distribution

Distributed to North Carolina.

## Key facts

- **Recall number:** Z-1250-2022
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-05-03
- **Report date:** 2022-06-15
- **Termination date:** 2024-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Republic, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2022

## Citation

> AI Analytics. FDA recall Z-1250-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1250-2022. Source: US FDA. Licensed CC0.

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