FDA Class I Recall for Megadyne's MEGA 2000 and MEGA Soft Electrodes

What: The MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes.

Why: The MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes can cause serious injuries or death.

Who: Megadyne Medical Products, Inc., a Johnson & Johnson Ethicon subsidiary.

When: The recall was issued on June 1st, 2023.

Where: The Megadyne Medical Products recall takes place nationwide.

How Can I Identify the Product?: Megadyne customers can identify the product by its product name and code.

On June 1st, 2023, the US Food and Drug Administration (FDA) issued a Class I product recall notice for Megadyne’s MEGA 2000 and MEGA Soft reusable patient return electrodes due to the risk of severe burns to patients. A Class I Recall label is the FDA’s most serious type of recall, and as noted in the recall, the use of the devices may cause severe injury or death. 

The recall was issued after Megadyne received over 60 reports from both pediatric and adult patients suffering from burn injuries. In some cases, the patients suffered from third-degree burns and required medical attention, extended hospital stays, scarring, and potentially more surgeries. There have been no reported deaths, and Megadyne is only aware of the reported 63 injuries. The company continues to evaluate the root cause of patient burns and claims they will alert customers if further actions are necessary to use the devices safely.

The MEGA 2000 and MEGA Soft reusable patient return electrodes are soft pads used during electrosurgery, during which an electric current is used to either heat, cut tissue, or stop bleeding. The electrical current is generated and sent to the tissue using a small pen-like electrosurgical generator. During electrosurgery, a return electrode pad is used to contact the skin of the laying patient and conduct the electric current from the patient’s tissue back to the electrosurgical unit or generator, lowering the risk of excessive heating.

The product names and codes currently listed in this recall include the following:

• MEGADYNE MEGA 2000 Patient Return Electrode 0800
• MEGADYNE MEGA SOFT Reusable Patient Return Electrode 0830
• MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode 0835
• MEGADYNE MEGA SOFT Pediatric Patient Return Electrode 0840
• MEGADYNE MEGA SOFT Universal Patient Return Electrode 0845
• MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode 0846
• MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode 0847
• MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode 0848

According to the reports, the surgical devices were distributed between March 11th, 2021, and May 9th, 2023, and 21,200 devices were recalled in the United States alone. 

Megadyne Sends Out Informational Letters To Help Reduce Injury Risk

According to a statement released by a Johnson & Johnson representative, they claimed that during an investigation into the patient burns reports–they found that the burns reported after surgical procedures in which Mega Soft pads were one of the devices used, it was determined that “in some instances, the Mega Soft pad Instructions for use were not being properly followed.”

Due to this finding, on June 1st, 2023, and in collaboration with the FDA, Megadyne issued a notification letter to the healthcare professionals who purchased the Mega Soft pads and all of the users involved in cleaning the operating room, patient setup and device operation during procedures. In their notice, they highly emphasized the importance of following the instructions for use, going as far as to include the proper cleaning and setup to help reduce the risks of potential burns. 

Along with urging their customers to follow proper protocol to reduce the risk of injuries, they also asked that the “Cleaning and Care Visual Aid and Placement and Setup Visual Aid” be posted near the operating room to remind staff about instructions for cleaning and setup. To further clarify, the company letter went on to remind their customers that the notification was not for product removal and that Mega Soft pads may continue to be used. 

Although the FDA Class I recall label stands, Megadyne says that “the Mega Soft pads remain available and, when used in accordance with the product’s labeling, are a safe alternative to disposable return electrodes.” If you or someone you know has undergone surgery and has suffered burns or has died due to the use of the MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, we may be able to help. 

For more information regarding this recall or how a Morgan & Morgan attorney may be able to help you, contact us today by completing our free, no-obligation case evaluation form.