J&J Electrode Pads Class I Recall

J&J Electrode Pads Class I Recall

The recent recall of Megadyne’s electrode pads has sent shockwaves through the healthcare community. Classified as a Class I event by the U.S. Food and Drug Administration (FDA), these electrode pads pose a serious risk of injury or death for patients. The FDA has received dozens of reports of severe burns among both adult and pediatric patients. While no deaths have occurred in connection with the recall, the root cause of the J&J electrode pads Class I recall remains undetermined.  

MEGA 2000 and MEGA SOFT Electrode Pads 

Megadyne is a subsidiary of Johnson & Johnson’s Ethicon segment. It is a well-known company specializing in the production of electrosurgical tools used in operating rooms worldwide. Electrosurgery incorporates high-frequency electric currents to perform various medical procedures, such as heating or cutting tissue and stopping bleeding.   

One essential component of electrosurgical procedures is the electrode pad. These pads are applied to a patient’s skin to conduct the electric current safely. Electrode pads like Megadyne’s MEGA 2000 and the MEGA SOFT Patient Return Electrodes are supposed to prevent excessive heating that could potentially cause harm. By facilitating the proper flow of electricity, electrode pads play a vital role in reducing the risk of complications during electrosurgical interventions. 

FDA Announces J&J Electrode Pads Class I Recall 

On June 1, 2023, Megadyne initiated a recall of over 21,000 units of its electrode pads. The company issued the recall after receiving troubling reports of severe burns associated with the electrosurgery tools. Consequently, the FDA identified this as a Class I recall, the most serious type of recall. The MEGA 2000 and MEGA Soft devices distributed between March 11, 2021, and May 9, 2023, could result in third-degree burns. Megadyne is aware of 63 injuries connected to the J&J electrode pads Class I recall.  

The FDA cautioned that patients burned by the recalled electrode pads may require a longer hospital stay, scarring, and potentially more surgeries due to their injuries.  

Megadyne Conducts Investigation  

In response to the complaints and concerns raised regarding their electrode pads, Megadyne investigated to identify potential factors contributing to the reported burns. Megadyne reportedly found no evidence of design or manufacturing defects that could be directly attributed to the problem. However, the investigation did shed light on a potential contributing factor in some cases: failure to follow the instructions for use. 

Megadyne claims that some users may not have adhered to the recommended guidelines. This could have played a role in the occurrence of burns. The company stressed the importance of thoroughly rinsing the MEGA Soft pads to remove any trace of cleaning solutions. According to their statement, failure to rinse off cleaning solution residue could lead to burn injuries. User error may have contributed to a portion of the reported burns. But other factors could also be at play, as Megadyne did not specify the underlying cause of the J&J electrode pads Class I recall.  

Recommendations Going Forward for J&J Electrode Pads Class I Recall 

In the Urgent Medical Device Correction letter sent to customers, Megadyne outlined a number of recommended actions, including:  

  • Share the notification with all users involved in the cleaning, operating room and patient setup, and device operation during procedures. 
  • Confirm that everyone is following instructions for use detailed in the letter.  
  • Post the “Cleaning and Care Visual Aid and Placement and Setup Visual Aid” for the electrode pads near the operations room to remind staff about proper usage.  

The Lake Law Firm will continue to monitor this product and any potential injuries linked to its use.