Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns

UPDATES:

In March 2025, Megadyne communicated in a letter the availability of a labeling (pad printing) update for Megadyne Mega Soft Universal (0845 & 0846) and Universal Plus (0847 & 0848) Reusable Patient Return Electrodes. The pad printing will now show the updated indication which is for patients age 12 years and older. Megadyne is initiating a voluntary product replacement program with the updated pad printing to customers with eligible unexpired Mega Soft Universal and Universal Plus Patient Return Electrodes. Customers can request a replacement by June 15, 2025. Customers who wish to continue to use their existing Mega Soft Universal and Universal Plus Patient Return Electrodes on patients 12 years or older may do so. Regardless of what is printed on the pad, Mega Soft Universal and Universal Plus Patient Return Electrodes should not be used for patients that are neonatal, infant, and children under the age of 12 years old.

Starting in September 2024, Megadyne communicated in a letter to new and existing customers reiterating the use of affected devices in patients aged 12 years and older. Additionally, Megadyne's letter informs customers that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no sheet).

The devices listed below are included in the FDA’s “Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers” issued on July 31, 2024.

The FDA reminds health care facilities and its staff not to use the Mega Soft Universal and Mega Soft Universal Plus for patients under the age of 12 years.

Please be aware, this recall is a correction, not a product removal.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. 

Recalled Product 

• Product Names: Megadyne Mega Soft Universal, Megadyne Mega Soft Universal Dual, Megadyne Mega Soft Universal Plus & Megadyne Mega Soft Universal Plus Dual 
• Product Codes: GEI
  • Class 1 Device Recall MEGADYNE MEGA SOFT Universal Patient Return Electrode (fda.gov)
  • Class 1 Device Recall MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode (fda.gov)
  • Class 1 Device Recall MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode (fda.gov)
  • Class 1 Device Recall MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode (fda.gov)
• Model Numbers: 0845, 0846, 0847, 0848
• Unique Device Identifiers: 10614559103906, 10614559104859, 10614559104842, 10614559104248
• Distribution Dates: October 1, 2021 to December 4, 2023 
• Devices Recalled in the U.S.: 9428
• Date Initiated by Firm: December 8, 2023; Updated March 2025

Device Use 

The Mega Soft Universal Patient Return Electrode is a medical device for surgeries involving use of electrosurgical instruments. It's designed to ensure the safety of the patient by providing a safe return path for the electrical current used in these procedures.

The electrode's purpose is to minimize the risk of electrical burns by ensuring the current flows safely through the patient's body and back to the electrosurgical unit, preventing any concentration of electrical energy in one area of the body. It's an important safety measure in procedures involving electrosurgery to protect the patient from electrical injury.

Reason for Recall   

Megadyne Medical Product, Inc. (Megadyne) is recalling family of Mega Soft Universal Patient Return Electrodes to update the Instructions for Use and product labeling to restrict use of the device to patients 12 years and older. 

Megadyne has received reports of patient burn injuries, including third-degree burns requiring intervention. Burn injuries may lead to extended hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.

Users should continue to follow the current Mega Soft Instructions for Use except for this new limitation in population of intended use.

As of the December 8, 2023, recall notice by the firm, there were 99 reported injuries. There have been no reports of death.

Who May be Affected  

• Adults and children undergoing electrosurgery that uses MEGA SOFT Universal Reusable Patient Return Electrodes. This product is not for use on children who are 12 years old or younger.
• Health care providers who use Megadyne Mega Soft Universal Patient Return Electrode to perform monopolar electrosurgery or who care for patients after surgeries that use these electrodes.

What to Do  

On March 13, 2025, Megadyne sent all affected customers a letter that described the following actions:

• Remind all users to only use Mega Soft Patient Return Electrodes on patients 12 years and older, even if existing devices have different labeling—such as “>0.35 kg (>0.8 lb)”—on the pads. Do not use them on neonates, infants, and children under the age of 12 years old.
• Complete Megadyne’s Business Reply Form Attachment A in its entirety to confirm receipt of Megadyne’s notice and send it to Sedgwick either by fax at 866-252-5331 or email to Ethicon8424@sedgwick.com. Return the form even if you are not requesting replacement.
• To request a replacement:
  • Select “Yes” on Attachment A of the Megadyne’s Business Reply Form.
  • Complete the replacement request form.
    • Provide an appropriate point of contact in the form. After the replacement request form is completed, a Megadyne representative will reach out about replacement timing and instructions.
  • As needed, continue using the Mega Soft Patient Return Electrodes you have until someone from Megadyne contacts you to coordinate the replacement.
  • Request replacement products by June 15, 2025.

Previously, on December 8, 2023, Megadyne sent all affected customers an Urgent medical device correction notice that requested customers to confirm with all users that the intended use changed to patients aged 12 years and older, and follow proper cleaning, placement, and setup steps for the Mega Soft pad.

Contact Information  

Customers in the U.S. who need additional copies of Megadyne’s March 2025 communication or have questions about returning the Business Reply Form should contact Sedgwick at 866-552-4916 and reference Event # 8424.

Customers in the U.S. with questions about this recall should contact Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).

Additional Resources:  

• Medical Device Recall Database Entry – 0845 
• Medical Device Recall Database Entry – 0846
• Medical Device Recall Database Entry – 0847
• Medical Device Recall Database Entry – 0848
• Urgent: Medical Device Correction Notice
• Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.