Megadyne Medical Products, Inc. is recalling approximately 4,306 Mega 2000 and Mega Soft Reusable Patient Return Electrodes. These large surgical pads, used during electrosurgery to safely conduct electrical current away from a patient's body, have been associated with reports of patient burns. While the pads were previously marketed for patients weighing over 25 pounds, this recall limits their use to patients aged 12 years or older to mitigate the risk of serious injury. The affected models include the Mega 2000, Mega Soft Single Cord, and Mega Soft Dual Cord pads distributed nationwide and internationally.
The pads can cause severe skin burns during surgical procedures when used on younger patients. This risk was identified through reports of patient burns, leading the manufacturer to restrict the device's use to older pediatric patients and adults.
Usage restriction and potential manufacturer guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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