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 - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor Recalled by ROi CPS LLC Due to Labeling error, incorrect expiration date.

Date: October 12, 2020
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 - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.

Quantity: 220 kits

Why Was This Recalled?

Labeling error, incorrect expiration date.

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