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FDAJune 17, 2024device

Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing ove...

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

The hazard

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

What to do

FDA enforcement status: Ongoing

Brands named

megadyne medical productsmegadynemegadyne medical

UPCs

10614559101797

Recall history

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

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