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FDADecember 8, 2023device

Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

What to do

FDA enforcement status: Ongoing

Brands named

megadyne medical productsmegadynemegadyne medical

UPCs

10614559104842

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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