Megadyne Medical Products, Inc.: MEGADYNE MEGA SOFT Return Electrodes Recalled Due to Burn Risks

Agency Publication Date: December 26, 2023

Summary

Megadyne Medical Products, Inc. has issued a recall for approximately 15,471 MEGADYNE MEGA SOFT Universal and Universal Plus Patient Return Electrodes because they have been linked to patient burn injuries, including severe third-degree burns. These reusable pads are used during surgery to safely conduct electrical current away from a patient's body, but reports indicate they may cause heat-related injuries requiring prolonged hospital stays and additional surgeries. As a result, the manufacturer is restricting the use of these specific models to patients aged 12 years and older only. If you have a procedure scheduled, you should contact your healthcare provider to ensure the appropriate equipment is being used.

Risk

The electrodes can cause unintended heat buildup leading to third-degree burns, scarring, and the need for medical intervention in both children and adults. Pediatric patients appear to be at particular risk, leading to the new age restriction for these devices.

What You Should Do

Identify if your facility uses MEGADYNE MEGA SOFT Universal or Universal Plus Patient Return Electrodes by checking the product codes and UDI-DI numbers on the device or packaging.
Check for Product Code 0845 (UDI-DI 10614559103906), Product Code 0846 (UDI-DI 10614559104248), Product Code 0847 (UDI-DI 10614559104842), and Product Code 0848 (UDI-DI 10614559104859).
Immediately limit the use of these specific electrodes to patients who are 12 years of age or older.
If you are a patient scheduled for surgery, consult with your surgeon or healthcare provider to confirm that the equipment used during your procedure is appropriate for your age and medical needs.
Healthcare providers should contact Megadyne Medical Products, Inc. for further instructions, updated labeling, or information regarding a potential refund or replacement at 1-888-463-6332.
For additional questions or to report an injury, contact the FDA's consumer hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Age restriction and usage limitation

How to: Limit use of affected product codes to patients age 12 years or older. Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: MEGADYNE MEGA SOFT Universal Patient Return Electrode (Product Code 0845)

Model / REF:

0845

UPC Codes:

10614559103906

Lot Numbers:

All units within Expiry

Product: MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode (Product Code 0846)

Model / REF:

0846

UPC Codes:

10614559104248

Lot Numbers:

All units within expiry

Product: MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode (Product Code 0847)

Model / REF:

0847

UPC Codes:

10614559104842

Lot Numbers:

All units in expiry

Product: MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode (Product Code 0848)

Model / REF:

0848

UPC Codes:

10614559104859

Lot Numbers:

All units within expiry

Product Images

“ Label for Megadyne Universal Dual Patient Return Electrode Pad

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93597

Status: Active

Manufacturer: Megadyne Medical Products, Inc.

Sold By: Medical distributors; Direct hospital sales

Manufactured In: United States

Units Affected: 3 products (9,587 ea; 3,572; 2,312)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your facility uses MEGADYNE MEGA SOFT Universal or Universal Plus Patient Return Electrodes by checking the product codes and UDI-DI numbers on the device or packaging.

Check for Product Code 0845 (UDI-DI 10614559103906), Product Code 0846 (UDI-DI 10614559104248), Product Code 0847 (UDI-DI 10614559104842), and Product Code 0848 (UDI-DI 10614559104859).

Immediately limit the use of these specific electrodes to patients who are 12 years of age or older.

If you are a patient scheduled for surgery, consult with your surgeon or healthcare provider to confirm that the equipment used during your procedure is appropriate for your age and medical needs.

Healthcare providers should contact Megadyne Medical Products, Inc. for further instructions, updated labeling, or information regarding a potential refund or replacement at 1-888-463-6332.

For additional questions or to report an injury, contact the FDA's consumer hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: MEGADYNE MEGA SOFT Universal Patient Return Electrode (Product Code 0845)

Model / REF:

0845

UPC Codes:

10614559103906

Lot Numbers:

All units within Expiry

Product: MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode (Product Code 0846)

Model / REF:

0846

UPC Codes:

10614559104248

Lot Numbers:

All units within expiry

Product: MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode (Product Code 0847)

Model / REF:

0847

UPC Codes:

10614559104842

Lot Numbers:

All units in expiry

Product: MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode (Product Code 0848)

Model / REF:

0848

UPC Codes:

10614559104859

Lot Numbers:

All units within expiry