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REASON FOR THE RECALL
According to the statement issued by Megadyne on June 1st, 2023, the electrodes products were recalled after receiving reports of pediatric and adult patients who received burn injuries from the devices.
These burns may be as serious as third-degree burns requiring medical intervention. They also could lead to a longer hospital stay, scarring, and potentially more surgeries for patients.
At this time Megadyne reported 63 injuries and no deaths related to the issue, but they are continuing to evaluate the root cause for patient burns. The recall affects a considerable sum of 21,200 devices that were distributed in the U.S. from March 11, 2012 to May 9, 2023. The product names and codes recalled are listed below:
- 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