Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns.

Megadyne Medical Products, Inc. has issued a recall for their Megadyne Mega Soft Universal Patient Return Electrodes. The recall is a correction, not a product removal, and has been classified as a Class I recall by the FDA, indicating that the use of these devices may cause serious injuries or death. The recall is due to reports of patient burn injuries, including third-degree burns, which may lead to extended hospital stays, scarring, and additional surgeries. The affected devices should only be used on patients aged 12 years and older, and healthcare providers who use these electrodes should follow the updated instructions for use. There have been 99 reported injuries, but no deaths. Customers with questions about the recall should contact the Ethicon Resource Department. [Extracted from the article]