Megadyne Medical Products, Inc. Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
Brand
Megadyne Medical Products, Inc.
Lot Codes / Batch Numbers
Product Code: 0830, UDI-DI: 10614559101797, Lot Number: All distributed lot numbers. Product code has been discontinued from future production.
Products Sold
Product Code: 0830; UDI-DI: 10614559101797; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.
Megadyne Medical Products, Inc. is recalling Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT due to To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE CORRECTION letter, dated 6/17/24, was mailed to consignees. Consignees are instructed to share the recall notification with all users of affected devices and confirm their understanding, post a copy of the communication for user awareness, and forward the recall notification to any facility to which product was shipped. The notification reads that Mega Soft and Mega 2000 devices are only to be used for patients 12 years old. The notification also reminds consignees to follow proper cleaning, placement, and setup steps. Consignees are asked to complete and return the provided Business Reply Form by fax to 844-441-2732 or by email to Ethicon8367@sedgwick.com. Customers with any questions about the communication can contact Ethicon at 1-877-384-4266 from Monday through Friday from 8:00 AM EST to 5:00 PM EST. UPDATE: Starting in September 2024, the firm communicated to new and existing consignees reiterating the use of affected devices in patients aged 12 years and older. Additionally, the firm's letter informs consignees that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no sheet).
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
Important Notice
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