INDIANA – Megadyne is recalling MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving reports of patients receiving burn injuries from use. These 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 pediatric and adult patients.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. The use of these devices may cause serious injuries, serious health consequences, or death.
