Megadyne Recalls Patient Return Electrodes

Megadyne Medical Product, Inc. is recalling its Mega Soft Universal Patient Return Electrodes to update its Instructions for Use and product labeling to restrict use of the device to patients 12 years and older. A recall notice says the company has received 99 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,” it says. “Users should continue to follow the current Mega Soft Instructions for Use except for this new limitation in population of intended use.”

The device is intended for surgeries involving use of electrosurgical instruments. “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,” according to the company.