Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

UNI-CP Recalled by NewDeal SA Due to Use of the impacted product may cause a...

Date: May 22, 2018
Company: NewDeal SA
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 NewDeal SA directly.

Affected Products

UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S

Why Was This Recalled?

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Where Was This Sold?

This product was distributed to 19 states: CA, CO, CT, ID, KS, MD, MA, MN, MS, MO, NY, NC, OH, OR, PA, SD, VA, WA, WI

Affected (19 states)Not affected

About NewDeal SA

NewDeal SA has 5 total recalls tracked by RecallDetector.

Related Recalls

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