Regard Item Number: 800214007 Sterile GS00367 - GASTRO… recallZ-1250-2022 · ROi CPS LLC · initiated May 3, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for the tip of the electrode to detach during use.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The firm sent out a recall notification on 05/03/2022 via email as well as the supplier's recall notice and label template to be used to label affected kits in the consignee's inventory. The recall notification letter informs the consignee to check their inventory, quarantine affected units, label affected kits, reply to the response form, and notify customers that were sent affected product. End users are to remove the affected items and discard them.
Recall details
- Recall number
- Z-1250-2022
- Status
- Terminated
- Initiated by the company
- May 3, 2022
- Recalling firm
- ROi CPS LLC
- Quantity
- 125 units
- Product code
- FDE
- FDA submissions
- K952204
- Distribution
- Distributed to North Carolina.
Product description
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Code information (models, lots, serial numbers)
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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ GS00367GRoi Cps, LLC · Laparoscopy Kit1 recall0 reports
Other devices under the same FDA submission
3 devices cleared under K952204 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- UNIVERSAL PLUS 60-5274-132Conmed Corporation · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES29 reports
- UNIVERSAL PLUS 60-5274-032Conmed Corporation · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES16 reports
- UNIVERSAL PLUS 60-5274-144Conmed Corporation · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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