(Reuters) – The U.S. Food and Drug Administration (FDA) on Tuesday classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson unit as the 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 Inc, which was acquired in 2017 by Ethicon Endo-Surgery Inc, a unit of J&J MedTech.
Ethicon did not immediately respond to a Reuters request for comment.
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.
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.
(Reporting by Mariam Sunny in Bengaluru; Editing by Pooja Desai)
