Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
Brand
Megadyne Medical Products, Inc.
Lot Codes / Batch Numbers
Model No. 0840, UDI-DI: 10614559103395, All Units.
Products Sold
Model No. 0840; UDI-DI: 10614559103395; All Units.
Megadyne Medical Products, Inc. is recalling MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery due to Firm has received reports of patient burns in surgical procedures where device was used.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm has received reports of patient burns in surgical procedures where device was used.
Recommended Action
Per FDA guidance
The firm distributed a recall notification by mail starting 06/01/2023. Customers are to provide the notice to all users of MEGADYNE MEGA SOFT and MEGA 2000 Reusable Patient Return Electrodes that participate in the cleaning, setup, and operation of affected devices. Megadyne has been made aware of 63 reports of serious patient burns since April 2018. The firm has attributed the incidence of burns to some instances that the Mega Soft Pad Instructions For Use were not being properly followed. Devices must be thoroughly rinsed after cleaning to ensure any cleaning residue is removed. Customers are asked to distribute the recall notification to all users, confirm that personnel are following the Instructions For Use, and post the provided informational attachments near the OR for staff member reference. If devices have been further distributed customers are to share the provided recall notice. Completed Business Reply Forms are to be faxed to Sedgwich at 888-214-7430 or emailed Ethicon5627@sedgwick.com. Any questions about the Business Reply Form can be made by phone to 888-843-0254 (Reference Event 5627). Any questions about this recall or to report a complaint can be made by phone to 1-877-384-4266, Monday thru Friday from 8:00 AM to 5:00 PM. Medical Engagement can be requested at https://www.jnjmedtech.com/mir.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
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