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: 800422 Recalled by Resource Optimization & Innovation Llc Due to The kits contain an equipment glove component which...

Date: April 22, 2015
Company: Resource Optimization & Innovation 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 Resource Optimization & Innovation Llc directly.

Affected Products

regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Quantity: 124 kits

Why Was This Recalled?

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Where Was This Sold?

This product was distributed to 3 states: LA, MS, TX

Affected (3 states)Not affected

About Resource Optimization & Innovation Llc

Resource Optimization & Innovation Llc has 224 total recalls tracked by RecallDetector.

Related Recalls

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