J&J limits use of Megadyne electrodes over burn risk

Johnson & Johnson (J&J) has restricted the use of three Megadyne patient return electrodes due to burn risks, specifying they should only be used for individuals aged 12 and older. This follows a similar action last year for four other electrode products.

The FDA reported 15 injuries and classified the recall as Class I, the most serious category. J&J's Mega Soft patient return electrodes, used during electrosurgery to protect patients by conducting electric currents back to the generator, were initially approved for patients over 25 lbs. Reports of burns prompted J&J to update the instructions, limiting use to those aged 12 and older, for Mega 2000, Mega Soft reusable, and Mega Soft dual reusable electrodes.

J&J's investigation found no design or manufacturing defects despite reports of burns, including third-degree burns. A June 2023 letter highlighted 63 serious burn complaints since April 2018. Additionally, J&J discontinued a pediatric electrode pad in May due to burn risks.