Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during Recalled by Megadyne Medical Products, Inc. Due to Firm has received reports of patient burns in...

Date: June 1, 2023
Company: Megadyne Medical Products, 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 Megadyne Medical Products, Inc. directly.

Affected Products

MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery

Quantity: 21,100 units

Why Was This Recalled?

Firm has received reports of patient burns in surgical procedures where device was used.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc. has 20 total recalls tracked by RecallDetector.

Related Recalls

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