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# Class 1 Correction Recall on Electrodes Updated
- URL: https://www.fdaweb.com/class-1-correction-recall-on-electrodes-updated/
- Published: 2024-03-01T12:00:00.000Z
- Updated: 2026-09-14T14:24:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156466

FDA has updated a Class 1 recall (correction) of Megadyne Medical Products’ Mega Soft patient return electrode models. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/megadyne-medical-products-inc-recalls-mega-soft-universal-patient-return-electrode-due-reports?ref=fdaweb.com) says the recall was to update the instructions for use and product labeling to restrict the use of the device to patients aged 12 years and older.

“Megadyne has received reports of patient burn injuries, including third-degree burns requiring intervention,” an earlier notice said. “There have been 99 reported injuries. There have been no reports of death.”

Since that notification, the company says it has continued to “monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd-degree patient burn.” The update reiterates that the devices should not be used for patients under the age of 12 years.

The patient return electrode is described as a medical device for surgeries involving the use of electrosurgical instruments. It reportedly is designed to ensure patient safety by providing a safe return path for the electrical current used in the procedures. The recall covers 9,428 units that were distributed between 10/1/2021 and 12/4/2023.