Megadyne Electrode Recall – How to File a Lawsuit

Megadyne Mega 2000 and Mega Soft patient return electrodes have been tied to burns in surgical patients, some as serious as third-degree. The FDA has classified two of the related recalls as Class I.

The recalls began in June 2023 and cover pads distributed from March 2021 to December 2023. Patients of any age who had electrosurgery may be affected.

Megadyne is part of Ethicon, a Johnson & Johnson MedTech company. Burned patients may bring individual claims. No MDL, class action or court case names these electrodes.

Latest Megadyne Electrode Lawsuit Updates

March 13, 2025: Megadyne Offers Replacement Pads

Megadyne wrote to affected customers about a labeling update and a voluntary replacement program. It covers Mega Soft Universal and Universal Plus electrodes, codes 0845, 0846, 0847 and 0848 [1].

The update changes the pad printing. The FDA recall notice says customers can request a replacement by June 15, 2025.

January 14, 2025: FDA Veterinary Letter Reports Animal Burns

The FDA’s Center for Veterinary Medicine sent a Dear Veterinarian letter about burn injuries in animals tied to veterinary use of Megadyne electrodes [2].

The letter names the MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 models. These are human medical devices, and the letter is addressed to veterinarians.

July 31, 2024: FDA and Health Canada Issue Safe-Use Letter

The FDA, together with Health Canada, issued a letter to health care providers on safe use of Mega 2000 and Mega Soft electrodes. It followed earlier recalls and corrections of these pads [3].

Providers should not use the Mega Soft Pediatric electrode, code 0840, at any age. They should use the other models only on patients 12 years and older.

May 10, 2024: Megadyne Recalls Mega Soft Pediatric Electrode

Megadyne announced a global discontinuation and voluntary recall of the Mega Soft Pediatric Patient Return Electrode, product 0840, after reports of patient burn injuries [4].

The company reported 4 injuries and no deaths between 2018 and the announcement. Customers should stop using the pad and return it. The FDA posted the announcement.

January 9, 2024: MassDevice Reports Class I Classification

MassDevice reported that the FDA classified Megadyne’s recall of its Mega Soft Universal patient return electrodes as Class I, the most serious kind [5].

The report says the electrodes are manufactured by J&J’s Ethicon. It followed the recall that Megadyne started on December 8, 2023.

December 8, 2023: Megadyne Recalls Mega Soft Universal Electrodes

Megadyne started a recall of the Mega Soft Universal family. It updates the labeling. The recall covers 9,428 devices distributed October 1, 2021 to December 4, 2023. As of that notice, 99 injuries and no deaths were reported.

July 12, 2023: MedTech Dive Reports Class I Classification

MedTech Dive said the FDA ranked the recall of 21,200 MEGA 2000 and MEGA Soft reusable electrodes from Megadyne as Class I [6].

The outlet said the agency cited the risk of serious burn injuries in a Tuesday notice. The classification followed Megadyne’s June 1, 2023 recall of these electrodes.

June 16, 2023: Health Canada Publishes Type II Recall

Health Canada published a Type II recall of Megadyne Mega Soft patient return electrodes in Canada, identification number RA-73835 [7].

The recall start date was June 6, 2023. Megadyne is aware of 63 complaints of serious patient burns globally since April 2018.

June 1, 2023: Megadyne Recalls Mega 2000 and Mega Soft Electrodes

Megadyne recalled MEGA 2000 and MEGA Soft reusable patient return electrodes in the United States after reports of patient burns. It sent an Urgent Medical Device Correction letter.

The recall covers 21,200 devices distributed March 11, 2021 to May 9, 2023. Megadyne reports 63 injuries and no deaths related to this issue.

What Are Patient Return Electrodes?

According to the FDA, MEGA 2000 and MEGA SOFT reusable patient return electrodes are soft pads used during electrosurgery. In this surgery, an electric current heats or cuts tissue or stops bleeding.

The pad touches the skin of the patient. It carries the current from the tissue back to the electrosurgical generator, which lowers the risk of excessive heating [8].

Who May Be Affected?

Adults and children who had electrosurgery with a Megadyne MEGA 2000 or MEGA SOFT reusable patient return electrode may be affected. So may health care providers who used these pads or cared for such patients afterwards.

The FDA warns that burn injuries may lead to long-lasting impacts on patients, especially under the age of 12 years. Only an individual legal review of your records can say whether you qualify for a claim.

The FDA and Megadyne report injuries for each recall separately, so the counts are not added together:

• Mega 2000 and Mega Soft: 21,200 devices, 63 injuries, no deaths.
• Mega Soft Universal family: 9,428 devices, 99 injuries, no deaths.
• Mega Soft Pediatric pad, now withdrawn: 4 injuries, no deaths.

Reported Injuries or Damages

The FDA’s July 31, 2024 safety letter reports burns from the electrodes in pediatric and adult patients. These burns may be as serious as third-degree burns requiring medical intervention.

They may lead to a longer hospital stay, scarring and potentially more surgeries. These are agency and company incident reports. They are not findings in a court case. The letter does not find that the electrodes caused every burn.

The FDA’s veterinary letter adds reports of burn injuries in animals linked to veterinary use of the same electrodes. It names three of the models above.

Recall and Regulatory Background

Megadyne has run four voluntary recalls since June 2023, the FDA letter says. They include the Mega 2000 and Mega Soft pads, the Mega Soft Universal family and the Mega Soft Pediatric 0840.

The first two are Class I corrections, not product removals, while the Pediatric pad was withdrawn. A recall does not prove liability.

Evidence to Preserve

Keep any record that shows which electrode was used, when it was used and how the burn was treated:

• The product name and code, and the lot or UDI, from the pad or its packaging.
• Operative and discharge records that name the electrode used.
• Hospital billing and the procedure date.
• Photographs of the burn over time.
• Burn clinic, wound-care, scarring and follow-up surgery records.
• Receipts for out-of-pocket costs.
• Any letters from Megadyne or the hospital.
• Copies of any reports you filed with the FDA.

Filing Deadlines

Deadlines to file an injury claim come from state law. They vary with where you live and when the burn happened and was discovered.

Some states count the time from the injury, and others count from when it was found. If you miss the deadline, your burn claim may end, whatever the evidence shows. Talk to a lawyer promptly.

Frequently Asked Questions

Which Megadyne Electrode Models Were Involved?

The Megadyne electrode models involved are Mega 2000 and Mega Soft. They also include Mega Soft Dual, Mega Soft Universal, Universal Dual, Universal Plus, Universal Plus Dual and Mega Soft Pediatric.

Has Megadyne Named a Root Cause for the Electrode Burns?

Megadyne has not named a root cause for the electrode burns. The FDA says the company is still evaluating. In its notice, last updated July 14, 2023, Health Canada says Megadyne found the Mega Soft pad Instructions for Use (IFU) were not always followed.

Where Can I Report a Megadyne Electrode Burn?

You can report a Megadyne electrode burn to the FDA. Questions about the electrodes go to the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266), the contact listed in the FDA notice.

What Does the Research Say About Megadyne Electrode Burns?

The research on Megadyne electrode burns so far comes from FDA reports. The FDA received animal burn reports that included dogs of varying weights and ages, tied to veterinary use of these human medical devices.

References

1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/megadyne-medical-products-inc-recalls-mega-soft-universal-patient-return-electrode-due-reports
2. https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-advising-veterinarians-burn-risk-associated-use-megadyne-grounding-pads
3. 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
4. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient
5. https://www.massdevice.com/megadyne-medical-recall-electrodes-class-i/
6. https://www.medtechdive.com/news/megadyne-electrode-recall-class-i-burn-risk/686612/
7. https://recalls-rappels.canada.ca/en/alert-recall/megadyne-mega-soft-patient-return-electrode
8. https://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn