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 NEWBORN KIT Recalled by ROi CPS LLC Due to Instructions for use updated to include the following...

Date: June 14, 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 NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.

Quantity: 608 units

Why Was This Recalled?

Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."

Where Was This Sold?

Missouri

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