Please be aware, this recall is a correction, not a product removal.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names: Megadyne Mega Soft Universal, Megadyne Mega Soft Universal Dual, Megadyne Mega Soft Universal Plus & Megadyne Mega Soft Universal Plus Dual
- Product Codes: GEI
- Class 1 Device Recall MEGADYNE MEGA SOFT Universal Patient Return Electrode (fda.gov)
- Class 1 Device Recall MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode (fda.gov)
- Class 1 Device Recall MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode (fda.gov)
- Class 1 Device Recall MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode (fda.gov)
- Model Numbers: 0845, 0846, 0847, 0848
- Distribution Dates: October 1, 2021 to December 4, 2023
- Devices Recalled in the U.S.: 9428
- Date Initiated by Firm: December 8, 2023
The Mega Soft Universal Patient Return Electrode is a medical device for surgeries involving use of electrosurgical instruments. It's designed to ensure the safety of the patient by providing a safe return path for the electrical current used in these procedures.
The electrode's purpose is to minimize the risk of electrical burns by ensuring the current flows safely through the patient's body and back to the electrosurgical unit, preventing any concentration of electrical energy in one area of the body. It's an important safety measure in procedures involving electrosurgery to protect the patient from electrical injury.
Reason for Recall
Megadyne Medical Product, Inc. is recalling family of Mega Soft Universal Patient Return Electrodes to update the Instructions for Use and product labeling to restrict use of the device to patients 12 years and older.
Megadyne has received reports of patient burn injuries, including third-degree burns requiring intervention. Burn injuries may lead to extended hospital stay, scarring, and additional surgeries in both pediatric and adult patients. Severe burns could lead to potentially long-lasting impacts on patients especially under the age of 12 years.
Users should continue to follow the current Mega Soft Instructions for Use except for this new limitation in population of intended use.
There have been 99 reported injuries. There have been no reports of death.
Who May be Affected
- Adults and children undergoing electrosurgery that uses MEGA SOFT Universal Reusable Patient Return Electrodes. This product is not for use on children who are 12 years old or younger.
- Health care providers who use Megadyne Mega Soft Universal Patient Return Electrode to perform monopolar electrosurgery or who care for patients after surgeries that use these electrodes.
What to Do
On December 8, 2023, Megadyne Medical Products, Inc. sent all affected customers an URGENT medical device correction notice.
The letter requested customers to:
- Share this information with all users of Mega Soft Universal and Universal Plus pads and confirm with all users that the intended use is changing to patients aged 12 years and older.
- Post a copy of this communication to remind staff not to use the Mega Soft Universal and Mega Soft Universal Plus pads on patients under 12 years old.
- Contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266) if medical engagement with manufacturer is needed.
- Complete the Business Reply Form, included with this letter, and fax or email it to Sedgwick within three business days.
- Follow proper cleaning, placement, and setup steps for the Mega Soft pad.
Customers in the U.S. with questions about this recall should contact Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).
- Medical Device Recall Database Entry – 0845
- Medical Device Recall Database Entry – 0846
- Medical Device Recall Database Entry – 0847
- Medical Device Recall Database Entry – 0848
- Urgent: Medical Device Correction Notice
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.