Mega Soft Patient Return Electrode is Not Kid-Friendly

Megadyne’s Mega Soft Universal Patient Return Electrode needs corrected labeling instructions restricting use to patients 12 and older, prompting an FDA Class I recall.

The electrode, designed to safely transfer current through a patient’s body and return to the electrosurgical unit, has led to a reported 99 burn injuries. The Class 1 correction recall requires Mega Soft users to follow the new guidelines prohibiting product use for children under age 12.

The company, which sent all affected customers an urgent medical corrected device notice on Dec. 8, 2023, had two patient electrode pads — including Mega Soft — recalled by the FDA last summer after reports of burn injuries.

Read the FDA’s recall notice here.

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