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# Alert on Megadyne Patient Return Electrodes
- URL: https://www.fdaweb.com/alert-on-megadyne-patient-return-electrodes/
- Published: 2024-07-31T12:00:00.000Z
- Updated: 2026-09-14T14:37:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157474

FDA and Health Canada are alerting healthcare providers and facilities about the safe use of Megadyne Medical Products’ Mega 2000 and Mega Soft Patient Return Electrodes, which have been at the center for four recalls since 6/2023 over reports of burn injuries in pediatric and adult patients and healthcare providers. “The reports of burns include up to third-degree burns requiring intervention, which may lead to prolonged hospital stay, scarring, and additional surgeries,” an [agency notice](https://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-megadyne-mega-2000-and-mega-soft-patient-return-electrodes-letter-health-care-providers?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “Burn injuries may lead to long-lasting impacts on patients, especially under the age of 12 years.”

According to the FDA alert, healthcare providers should follow the instruction in Megadyne’s recall notifications, such as:

- Do not use Mega Soft Pediatric Patient Return Electrodes (product code 0840) in any age group;
- Only use Mega 2000 and Mega Soft Patient Return Electrodes (product codes: 0800, 0830, 0835, 0845, 0846, 0847, and 0848) on patients aged 12 years and older.

FDA says patient return electrodes are used during monopolar electrosurgery. The devices are intended to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units or generators, it says.

The agency says it is working with Megadyne to update the labeling for affected products (including the printing on the pads that will continue to be manufactured), and to continue to monitor device performance and burn reports.