Regard Item Number: 800214007 Sterile GS00367 — Class II medical device recall Z-1250-2022
Terminated recall by ROi CPS LLC, reported 2022-06-15, distributed in NC. Potential for the tip of the electrode to detach during use.
| Recall number | Z-1250-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2022-05-03 |
| Classified | 2022-06-08 |
| Reported by FDA | 2022-06-15 |
| Terminated | 2024-05-31 |
| Distributed | NC |
| Quantity | 125 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10194717101024 |
| Lot numbers | 88207G |
| Model numbers | 60-5274-944, 60-5274-944-NEEDLE, 800214007, GS00367G |
| Expiration dates | 2023-05-11, 2023-05-26, 2023-06-02, 2023-07-02, 2024-01-07 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1250-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.