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…

Read more
  • 0