July 11, 2023

FDA: Class I recall of Megadyne’s Mega 2000, Mega Soft reusable patient return electrodes

By: Judy Mathias

Tags: electrosurgical instruments, FDA, Patient Safety, Product recall

Editor's Note

The Food and Drug Administration (FDA), on July 11, identified the recall by Megadyne of its Mega 2000 and Mega Soft reusable patient return electrodes as Class I, the most serious.

The recall was initiated after Megadyne received reports of pediatric and adult patients receiving burn injuries during surgical procedures in which monopolar electrosurgical instruments were used.

The company reports 63 injuries and no deaths related to this issue. Distribution dates were March 11, 2021, to May 9, 2023.

FDA: Class I recall of Megadyne’s Mega 2000, Mega Soft reusable patient return electrodes

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