Class II — Potential Health Hazard

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

Coapt ControlSeal Electrode Recalled by Coapt LLC Due to Patient may experience minor burn or blistering if...

Date: October 2, 2023
Company: Coapt LLC
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 Coapt LLC directly.

Affected Products

Coapt ControlSeal Electrode, cutaneous EMG Electrode

Quantity: 109 devices

Why Was This Recalled?

Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Coapt LLC

Coapt LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

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