Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - Recalled by ROi CPS LLC Due to Potential for the tip of the electrode to...

Date: May 3, 2022
Company: ROi CPS LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ROi CPS LLC directly.

Affected Products

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

Quantity: 125 units

Why Was This Recalled?

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

Where Was This Sold?

Distributed to North Carolina.

About ROi CPS LLC

ROi CPS LLC has 86 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report