Megadyne Medical Products, Inc. Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus 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
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
Brand
Megadyne Medical Products, Inc.
Lot Codes / Batch Numbers
UDI-DI 10614559104859 All units within expiry
Products Sold
UDI-DI 10614559104859 All units within expiry
Megadyne Medical Products, Inc. is recalling Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient due to Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and incl. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Recommended Action
Per FDA guidance
On December 8, 2023, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. The updated IFU will be made available electronically at www.e-ifu.com. Customers were instructed to share the notification update with all users of Mega Soft Universal and Universal Plus pads, and to take steps to ensure that all personnel using the affected product understand and are reminded that the product is not to be used on patients under 12 years old. If you have additional questions regarding this communication or to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET. 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). On 3/17/25, customers were customers were notified via MEGADYNE MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrode: Voluntary Replacement Program letters. The purpose of this letter is to communicate the availability of a labeling (pad printing) update for MEGADYNE" MEGA SOFT" Universal and Universal Plus Reusable Patient Return Electrodes and availability of these pads for replacement of your current inventory. The pad printing will now show the updated indication which is for patients age 12 years and older. The previous pad printing indicates use for patients greater than 0.8 lbs (0.35 kg). Actions Required 1. Reminder users to only use Mega Soft Patient Return Electrodes on patients 12 years and older, even though these existing devices have labeling of >0.35 kg (>0.8 lb) on the pads. Do not use them on neonates, infants, and children under the age of 12 years old. 2. Compl
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026