MEGADYNE has initiated a voluntary recall of all MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes after “reports of patient burn injuries.” The FDA has the report.
An investigation on the reports “included testing which showed a combination of factors when present together may result in potential for thermal injuries.” These factors are more likely to occur “when the pad is used with infants and small children. 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.”
Between 2018 and May 10, 2024, “there have been 4 reported injuries and no reports of death associated with this product.” Customers who have the product should “stop using them and return them.”
