The FDA has announced a Class I Recall for more than 21,000 Megadyne Patient Return Electrodes after 99 reports of severe burn injuries in both children and adult patients.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Megadyne Electrode induced injury cases in all 50 states. If you or somebody you know was burned by a MEGA 2000 or MEGA Soft Reusable Patient Return Electrode, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
UPDATE: MegaDyne Recalls Mega Soft Electrodes After 99 Injuries Reported
In January 2024, Megadyne Medical Products issued a recall for Mega Soft Universal Patient Return Electrodes after 99 reported injuries. MegaDyne has restricted the product to patients over the age of 12 years old.
According to the recall announcement:
“Megadyne has received reports of patient burn injuries, including third-degree burns requiring intervention. Burn injuries may lead to extended hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.”
J&J’s Ethicon Recalls Megadyne Electrodes Over Burn Risk
Johnson & Johnson subsidiary Ethicon, Inc., issued the MEGA 2000 and MEGA SOFT Reusable Patient Return Electrode recall [1.] on June 1, 2023, following at least 63 reports of serious burn injuries in patients treated with the electrodes.
“These burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for pediatric and adult patients,” FDA said.”The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.”
Which Megadyne Electrodes are Affected by the Recall?
Products affected by the Megadyne electrode recall were distributed from March 11, 2021, to May 9, 2023, and include:
- MEGADYNE MEGA 2000 Patient Return Electrode 0800
- MEGADYNE MEGA SOFT Reusable Patient Return Electrode 0830
- MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode 0835
- MEGADYNE MEGA SOFT Pediatric Patient Return Electrode 0840
- MEGADYNE MEGA SOFT Universal Patient Return Electrode 0845
- MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode 0846
- MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode 0847
- MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode 0848
What are Megadyne Patient Return Electrodes?
MEGA 2000 and MEGA Soft reusable patient return electrodes are soft pads used in certain surgeries to reduce the risk of excessive heating when an electric current is used to heat, cut tissue, or stop bleeding.
What Causes Return Electrode Burns?
Although it is still uncertain as to why Megadyne electrodes are injuring patients, there are a number of possible reasons for pad-site burns. Long duty cycles and high generator power settings may contribute to pad-site burns. Additionally, placement of adhesive return electrodes over bony prominences, scar tissue, metal prostheses, hair, tattoo, potential pressure points or fluid may also lead to pad-site injury.
Do I have a Megadyne Electrode Lawsuit?
The Schmidt Firm, PLLC is currently accepting Megadyne Electrode induced injury cases in all 50 states. If you or somebody you know was burned by a MEGA 2000 or MEGA Soft Reusable Patient Return Electrode, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
