FDA Classifies Recall of J&J’s Electrosurgical Tools as Most Serious

The U.S. Food and Drug Administration (FDA) on Tuesday classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson unit as “most serious,” saying their use could lead to injuries or death.

The U.S. health regulator said it had received reports of pediatric and adult patients suffering burn injuries when the tools, sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, were used on them.

The tools are soft pads that conduct an electric current through the patient’s body during electrosurgical procedures to heat or cut tissue, or stop bleeding.

The tools were recalled by Megadyne Medical Products, which was acquired in 2017 by Ethicon Endo-Surgery, a unit of J&J MedTech.

Megadyne received reports of 63 injuries and no deaths related to the use of the devices and is continuing to evaluate the root cause for patient burns, the FDA said in a statement.

J&J MedTech said during the investigation into burn injuries related to use of the devices, it was determined that in some instances the products were not used properly.

The company said the products remain available and it had issued notifications in June to healthcare professionals to follow the correct instructions for use.

The regulator said Megadyne, in June 2023, initiated a recall of 21,200 units of the electrosurgery tools, distributed between March 11, 2021 and May 9, 2023.