Megadyne Electrode Lawsuit | 2025 Latest Updates

Megadyne Electrode Lawsuit Overview

Megadyne Medical Products, Inc., a subsidiary of Johnson & Johnson’s Ethicon, has initiated multiple Class I recalls, the FDA’s most serious designation, for its reusable patient return electrodes due to reports of severe burn injuries.

The recalls affect models including the MEGA 2000, MEGA SOFT, MEGA SOFT Universal, Universal Dual, Universal Plus, and Universal Plus Dual, with approximately 21,200 devices recalled in the U.S. from March 11, 2021, to May 9, 2023, and 9,428 devices from October 1, 2021, to December 4, 2023. A separate recall in May 2024 discontinued and removed all MEGA SOFT Pediatric Patient Return Electrodes (product code 0840) due to burn risks in infants and children weighing 0.8 to 50 pounds.

Latest Megadyne Electrode Lawsuit Updates

• March 26, 2025 – The FDA issued a Class I recall for Megadyne’s Mega Soft Universal electrodes due to reports of serious patient burns during surgery—highlighting critical safety risks for patients and grounds for potential lawsuits.
• July 31, 2024 – Following reports of surgical burns, Megadyne issued a voluntary global recall of its pediatric Mega Soft electrodes. The FDA categorized this as a serious risk to child patients undergoing surgery.
• May 10, 2024 – Johnson & Johnson MedTech has voluntarily pulled Megadyne’s pediatric electrodes from global markets, citing safety concerns that could result in serious harm [1].

FDA Reports and Statistics

The FDA and Megadyne have emphasized that MEGA 2000 and MEGA SOFT electrodes should not be used on patients under 12 years old, as burns in this group, particularly third-degree, can lead to prolonged hospital stays, scarring, and additional surgeries. The FDA reports 99 injuries linked to MEGA 2000 and MEGA SOFT electrodes (63 from June 2023 and 15 additional by September 2024) and 4 injuries specifically tied to the MEGA SOFT Pediatric electrodes, with no reported deaths.

These injuries have spurred lawsuits alleging defective design, failure to warn, and negligence, with plaintiffs seeking compensation for medical expenses, pain, scarring, and emotional distress [2].

The combination of these conditions may be more likely when the pad is used with infants and small children, FDA said. Because the pediatric pad is designed for patients between 0.8 to 50 pounds, which would be predominantly patients under the age of 12, the decision was made to discontinue and recall the 0840 pediatric pad product.

Megadyne Electrode Injuries & Side Effects

Patients who have used Megadyne patient return electrodes may experience various injuries and complications. The most serious concerns include:

• Severe Burns: Full-thickness (third-degree) burns that destroy all skin layers and damage underlying tissues
• Scarring and Disfigurement: Long-term visible damage caused by deep burns or surgical intervention
• Additional Surgeries: Corrective procedures required to repair tissue damage
• Emotional Distress: Trauma resulting in depression, anxiety, and PTSD

Do You Qualify for a Megadyne Electrode Lawsuit?

You may qualify for a Megadyne Electrode lawsuit if:

• You or a loved one was treated with a Megadyne Patient Return Electrode during a surgical procedure between 2012 and 2023
• You experienced serious side effects including burns, scarring, or tissue damage
• The injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to the Megadyne device

Evidence Required for a Megadyne Electrode Lawsuit

Building a strong case requires comprehensive evidence that clearly links your injuries to the use of a Megadyne electrode:

• Medical Records: Detailed reports confirming the injuries sustained, surgeries performed, and ongoing treatments
• Device Usage Proof: Hospital or surgical records verifying that a Megadyne electrode was used during your procedure
• Incident Reports: Reports filed by healthcare facilities acknowledging the device’s malfunction or safety risks
• Expert Testimony: Medical device specialists who can confirm design flaws associated with Megadyne electrodes

Damages You Can Recover

Victims of Megadyne electrode burns may be eligible for compensation covering:

• Medical Expenses: Past, present, and future medical costs related to treating burn injuries, including surgeries, hospitalizations, and physical therapy
• Lost Wages: Compensation for income lost due to injury-related recovery time
• Pain and Suffering: Damages for long-term pain, emotional distress, and reduced quality of life
• Punitive Damages: If gross negligence by Megadyne is proven, additional damages may be awarded

Megadyne Electrode Recall Information

Products affected by the Megadyne Electrode recall include:

Distribution Details:

• Distribution Period: March 11, 2012 – May 9, 2023
• Age Restriction Alert: The Mega Soft Universal electrodes are restricted to patients aged 12 and older due to serious safety concerns

This is an FDA Class I Recall, which means that use of the product could result in serious injury or even death, the agency said.

Statute of Limitations for Megadyne Electrode Lawsuits

Time is limited when it comes to filing a lawsuit. The statute of limitations varies by state, ranging from two to four years from the date of injury or discovery of harm. Consulting an experienced attorney as soon as possible ensures your claim is filed within the correct legal window and protects your right to seek compensation.

FAQs

1. What is a Megadyne Electrode?

Megadyne Patient Return Electrodes are soft pads used on adults and children undergoing electrosurgery, in which an electric current is used to heat or cut tissue or to stop bleeding. The electric current is produced by an electrosurgical generator and delivered to the tissue with a small pen-like attachment. A return electrode pad contacts the skin of the patient and conducts the electric current from the patient’s tissue back to the generator to reduce the risk of excessive heating.

2. Why might there be a lawsuit related to the Megadyne Electrode?

A lawsuit might arise if the Megadyne Electrode is found to be defective or if its use results in serious injuries to patients. Issues such as manufacturing defects, design flaws, or inadequate instructions could lead to legal action against the manufacturer.

3. What should I do if I’ve been injured by a Megadyne Electrode during surgery?

If you’ve been injured, seek medical attention immediately to address any complications. Afterward, consult with an attorney who specializes in medical device litigation to explore your legal options, including potential compensation for your injuries.

4. Can I file a lawsuit if a loved one died due to complications from a Megadyne Electrode?

Yes, if a loved one died due to complications from a Megadyne Electrode, you may be eligible to file a wrongful death lawsuit. This type of lawsuit seeks compensation for the loss of your loved one, including funeral expenses and loss of companionship.

5. What evidence is needed to support a lawsuit involving the Megadyne Electrode?

Evidence may include medical records documenting the injury, expert testimony linking the device to the harm caused, and any documentation showing that the device was defective or used improperly during surgery.

6. How long do I have to file a Megadyne Electrode lawsuit?

The time limit (statute of limitations) varies by state, typically ranging from two to four years from the date of injury. It’s crucial to consult with an attorney promptly to ensure you don’t miss your filing deadline.

7. What is the expected settlement amount for Megadyne Electrode lawsuits?

As of April 2025, there have been no publicly reported settlements or jury verdicts in lawsuits against Megadyne. Settlement amounts often depend on the extent of injuries suffered, medical costs, and strength of evidence proving the device caused harm.

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Get a Free Megadyne Electrode Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action if you’ve been injured by a Megadyne Electrode. Many states have a statute of limitations of only 2-3 years from the date of injury, and waiting too long could forfeit your right to compensation.

Our services include:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees to begin your lawsuit
• Payment only if we win your case

Don’t delay in seeking the justice and compensation you deserve. Contact our experienced legal team today.

References:

1. https://www.jnjmedtech.com/en-US/news-events/megadyne-initiates-global-discontinuation-and-voluntary-recall-mega-soft-pediatric 
2. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient