FDA alerts to Class I recall of Mega Soft Universal Patient Return Electrode due to risk of serious injury, death

According to the FDA, a December 8, 2023 recall of Mega Soft Universal Patient Return Electrode by Megadyne Medical Products, Inc. has been identified as Class I, the most serious type. Consumers and healthcare professionals are warned that use of the affected devices could lead to major injuries or death.

A medical device implemented in surgeries involving electrosurgical instruments, the Mega Soft Universal Patient Return Electrode is indicated to protect a patient against the electrical current used in these specific procedures. The electrode allows the current to safely flow through the patient’s body and to be returned back to the electrosurgical unit with minimal risk of electrical burns. It is designed to prevent electrical energy from concentrating in any one portion of the body, and plays a critical part in protecting patients against electric injury during electrosurgery procedures.

Since December 8, 2023, 9,428 Mega Soft Universal Patient Return Electrode devices have been recalled across the U.S. The products were distributed between October 1, 2021 and December 4, 2023, and impacts devices under product code GEI and model numbers 0845, 0846, 0847, and 0848.

The specific names of the recalled devices are as follows:

  • Megadyne Mega Soft Universal
  • Megadyne Mega Soft Universal Dual
  • Megadyne Megal Soft Universal Plus
  • Megadyne Mega Soft Universal Plus Dual

Officials say the family of electrodes was recalled because the product labeling requires an update that aims to restrict device use to patients 12 years of age and older.

The action comes after Megadyne Medical Product, Inc. has received 99 reports of injuries. While no reports of death have been made, a number of reports detail up to third-degree burns to patients that necessitated intervention. Any burn injuries sustained from use of an affected product could put patients (both pediatric and adult) at risk of scarring and additional surgeries that may require longer hospital stays. Healthcare providers are advised that patients under the age of 12 should not use this device, as they could suffer severe burns that produce potentially longer-lasting consequences.

An “URGENT” medical device correction notice issued by Megadyne Medical Products, Inc. on December 8, 2023 made a number of requests:

  • Share updated information to all users of Mega Soft Universal and Universal Plus pads
    • confirm with all relevant parties that the intended use is to only include “patients aged 12 years and older.”
  • Post the communication in a high-traffic area in the facility to serve as a reminder to all staff of the intended use.
  • In the event that medical engagement with the manufacturer is necessary, contact Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266)
  • Complete and submit the Business Reply Form via fax or email to Sedgwick within three business days of reading the letter.
  • Adhere to the established cleaning, placement and setup protocols for the Mega Soft pad.

As the FDA continues to monitor the recall, healthcare professionals and consumers are asked to report any related adverse effects or quality issues to the agency’s MedWatch program.


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