Megadyne Medical recall of patient return electrodes is Class I

The Mega Soft Universal patient return electrode. [Image from Megadyne Medical]The FDA deemed a recall of some Megadyne Medical patient return electrodes, manufactured by J&J’s Ethicon, as Class I, the most serious kind.

This action is a correction, not a product removal.

Megadyne recalled its Mega Soft Universal, Universal Dual, Universal Plus and Universal Plus Dual patient return electrodes. It initiated the recall on Dec. 8, with the action affecting 9,428 devices distributed between Oct. 1, 2021, and Dec. 4, 2023.

The company initiated this recall to update the instructions for use and product labeling. It seeks to restrict device use to patients 12 years and older. Megadyne received reports of patient burn injuries, including third-degree burns requiring intervention. Burn injuries could lead to extended hospital stays, scarring and additional surgeries.

Severe burns could lead to potentially long-lasting impacts on patients, especial…

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  • January 9, 2024
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J&J’s Ethicon has a serious Megadyne electrode recall due to potential burns in electrosurgery

The Megadyne Mega Soft and Mega 2000 electrodes manufactured by J&J’s Ethicon. [Images from the FDA]The FDA labeled a recall of Megadyne electrode products manufactured by Johnson & Johnson’s Ethicon Class I, the most serious kind.

Recalled products include a number of Megadyne Mega Soft electrodes and the Mega 2000 patient return electrode. Ethicon paid an undisclosed amount to acquire Megadyne Medical Products in 2017 after several years of collaboration.

According to an FDA notice, the recall affects 21,200 devices in the U.S. The firm distributed those devices between March 11, 2021, and May 9, 2023, before initiating the recall on June 1, 2023.

Both the Mega 2000 and Mega Soft reusable patient return electrodes are soft pads used during electrosurgery. During these procedures, an electric current heats or cuts tissue or stops bleeding. An electrosurgical generator creates the electric current and a small, pen-like attachment deliver…

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  • July 11, 2023
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