Class II — Potential Health Hazard

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

Gladiator Recalled by North Coast Medical Inc Due to The thumb strap of the wrist and thumb...

Date: August 18, 2023
Company: North Coast Medical Inc
Status: Ongoing
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 North Coast Medical Inc directly.

Affected Products

Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)

Quantity: 27 units

Why Was This Recalled?

The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

Where Was This Sold?

This product was distributed to 3 states: CA, NC, WI

Affected (3 states)Not affected

About North Coast Medical Inc

North Coast Medical Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

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