Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns

Megadyne is correcting the MEGA SOFT, MEGA SOFT DUAL, and MEGA 2000 Patient Return Electrodes after receiving reports of patient burn injuries, especially in children under 12 years of age, after procedures where the MEGA 2000 and MEGA SOFT Patient Return Electrodes were used.

The FDA has identified this as a Class I recall, the most serious type of recall. This recall involves updating instructions for using these devices and does not involve removing them from where they are used or sold. This device may cause serious injury or death if you continue to use it without following the updated instructions.  

Questions?

Customers in the U.S. with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).