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 Ultrasound Tray Recalled by ROi CPS LLC Due to Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due...

Date: August 10, 2021
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 Ultrasound Tray

Quantity: 240 trays

Why Was This Recalled?

Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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