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

By Mariam Sunny, Khushi Mandowara

Based on reports of burn injuries among pediatric and adult patients, the U.S. Food and Drug Administration (FDA) has classified the recall of some electrosurgery tools manufactured by Megadyne Medical Products, a unit of Johnson & Johnson, as “most serious.” This means that use of the devices, with the brand names MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, could cause injuries or death. The FDA said 63 injuries, but no deaths, had been reported to Megadyne related to the tools, which are soft pads used during electrosurgical procedures to conduct an electric current through a patient’s body to heat or cut tissue or stop bleeding. Although Megadyne continues to evaluate the root cause for patient burns, J&J MedTech indicated that an investigation revealed the devices were used improperly in some cases. The recall covers 21,200 units distributed between March 11, 2021, and May 9, 2023.

Read more on Reuters.