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 Recalled by Resource Optimization & Innovation Llc Due to Custom procedure trays contain a component, a light...

Date: January 9, 2017
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: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills

Quantity: 590 kits

Why Was This Recalled?

Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

Where Was This Sold?

This product was distributed to 2 states: LA, TX

Affected (2 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