FDA Recalls Several J&J Medical Devices After Reports of Burn Injuries

Tuesday, the FDA issued a Class I recall of reusable patient return electrodes produced by Johnson and Johnson subsidiary Megadyne Medical Products after receiving reports of patients suffering burn injuries when the tools were used. The Class I recall is only employed when there is a reasonable probability that using a medical device poses the risk of serious adverse health consequences or death.

Megadyne, which J&J subsidiary Ethicon acquired in 2017, received reports of 63 injuries related to the devices used in pediatric and adult patients. The company’s recall affects 21,200 devices in the United States. According to Reuters, J&J Medtech claims that the product was improperly used in some instances, resulting in injury.

The MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes are used to reduce the risk of excessive heating during electrosurgery.

“Designed with patient safety in mind, the MEGADYNE MEGA SOFT Universal Plus Reusable Patient Return Electrode is designed to help prevent pad site burns by limiting heat build-up,” explains Ethicon’s product description. “This pad also offers the versatility to work for any size patient and is reusable for two years.”

As J&J continues to investigate the cause of injuries, it said that MEGA 2000 and MEGA SOFT products will remain available and that providers should review operating room procedures and other instruction manuals for the products.

Another recent Class I recall occurred when some Philips Respironics CPAP and BiPAP machines were found to deliver insufficient therapy, which could have led to failure to treat sleep apnea. In that recall notice, Phillips also recommended that patients continue to use their device unless it was inoperable or until a replacement could be made.

Last year, the FDA recalled 60 medical devices, three more than were recalled in 2021. So far, in 2023, there have been 21 recalls of medical devices, several of which were prompted because of potential harm to patients.

In a recent Emergency Care Research Institute (ECRI) report, the organization shared that the failure to communicate medical device recalls poses significant risks to patient safety. ECRI also claimed that patients often continue to use faulty or dangerous devices even after a recall has been issued because of insubstantial notification and a lack of understanding of recall classes.

The institute recommended that medical providers frequently monitor for recalls and share recall information with device users to avoid hazards.