Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes

The U.S. Food and Drug Administration (FDA), together with Health Canada, is raising awareness among health care providers and facilities about the safe use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, Inc.

Since June 2023, Megadyne has initiated four voluntary recalls due to reports of burn injuries in pediatric and adult patients and health care providers. Following the instructions in the manufacturer’s recall notifications can help ensure the safe use of these products. In summary:

• Do not use Mega Soft Pediatric Patient Return Electrodes in any age group (product code 0840)
• Only use Mega 2000 and Mega Soft Patient Return Electrodes on patients 12 years and older (product codes: 0800, 0830, 0835, 0845, 0846, 0847, and 0848)

The Letter to Health Care Providers includes important information about Mega 2000 and Mega Soft Patient Return Electrodes, including:

• Information on recalled products.

• Recommendations for health care providers and facilities.

• Background on the issue and the actions that the FDA is taking to address the issue.

• Instructions for reporting problems.

Questions?

If you have questions about this letter to health care providers, contact the Division of Industry and Consumer Education (DICE).