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# Megadyne Mega Soft Electrode Recall is Class 1
- URL: https://www.fdaweb.com/megadyne-mega-soft-electrode-recall-is-class-1/
- Published: 2024-01-17T12:00:00.000Z
- Updated: 2026-09-14T14:20:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156148

FDA says the Megadyne Medical Products 12/8/2023 recall (correction) of four Mega Soft patient return electrode models is Class 1\. 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 and older.

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

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.