Editor's note: This story has been updated to include comments from Johnson & Johnson regarding this notification. J&J emphasizes that this is not a product removal. However, FDA has classified it as a Class I recall.
Several types of Megadyne electrodes used in electrosurgery and manufactured by Johnson & Johnson's Ethicon business are being recalled due to the risk of serious burn injuries to patients.
According to the FDA recall notice, the company reported that 63 patients (pediatric and adult) received burn injuries from the Mega 2000 and Mega Soft electrodes. The burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for patients, FDA noted.
Megadyne, a company Ethicon acquired in 2017, is evaluating the root cause for patient burns, FDA said.
The Class I recall includes 21,200 devices distributed in the United States between March 11, 2021, and May 9, 2023. The company initiated the recall June 1.
Mega 2000 and Mega Soft reusable patient return electrodes are soft pads used during electrosurgery. During electrosurgery, an electric current is used to heat or cut tissue or to stop bleeding. The electric current is generated by an electrosurgical generator and delivered to the tissue with a small pen-like attachment (like the one shown in the image below). A return electrode pad contacts the skin of the laying patient during use and conducts the electric current from the patient’s tissue back to the electrosurgical unit, or generator, to reduce the risk of excessive heating.
"It is important to note that this notification was not a product removal. Mega Soft pads remain available and, when used in accordance with the products’ labeling, are a safe alternative to disposable return electrodes," Amanda Pisano, a spokesperson for Johnson & Johnson MedTech, told MD+DI in an email.
Pisano explained that during an investigation into reports of patient burns identified 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 (IFU) were not being properly followed.
"In collaboration with the United States Food and Drug Administration, we issued a notification to healthcare professionals who have purchased Mega Soft pads," she said. "The notification emphasized the importance of following the Instructions for Use (IFU), including proper cleaning and setup to help reduce the potential for a burn."
Megadyne sent an urgent medical device correction letter to customers that included the following recommended actions:
- Share the notification with all users involved in Mega 2000 and Mega Soft electrodes cleaning, operating room and patient setup, and device operation during procedures.
- Confirm that personnel using the electrodes are following the instructions for use.
- Post visual aids for cleaning and care and setup, both of which are attached to the letter, near the operating room to remind staff about instructions for cleaning and setup.
- Contact any facilities where products may have been shared.