ROi CPS LLC: Medical Device Recall in 2022 - (Recall #: Z-1250-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 3, 2022

Date Posted: June 15, 2022

Recall Number: Z-1250-2022

Event ID: 90135

Reason for Recall:

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

Status: Terminated

Product Quantity: 125 units

Code Information:

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)

Distribution Pattern:

Distributed to North Carolina.

Voluntary or Mandated:

Voluntary: Firm initiated