Megadyne Medical Products, Inc.: Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord

Recall number

Z-0598-2024

Recalling firm

Megadyne Medical Products, Inc.

Product

Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord

Status

Open, Classified

Initiated

2023-12-08

Posted

2023-12-26

Terminated

not on file

Reason

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.

Root cause

Under Investigation by firm

Action

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

Quantity

3,572

Distribution

Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Lebanon, Malaysia, Martinique, Morocco, Netherlands, New Caledonia, Norway, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian , Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam

Lot, serial or model codes

UDI-DI 10614559104248 All units within expiry

510(k) numbers

["K233644"]

PMA numbers

not on file

Product code

GEI

Firm FEI

1721194

Firm city

Blue Ash

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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