Megadyne Medical Products, Inc.: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode Recalled for Burn Risk

Agency Publication Date: June 6, 2024

Summary

Megadyne Medical Products, Inc. is recalling 1,270 units of the MEGADYNE MEGA SOFT Pediatric Patient Return Electrode (Model 0840) due to reports of patients suffering from burns during electrosurgical procedures. This reusable electrode is designed for pediatric patients weighing between 0.8 and 50 pounds. The recall was initiated following reports of patient injuries and applies to all distributed lot numbers of this specific pediatric model.

Risk

The electrode can cause unintended burns to pediatric patients during surgery, which can lead to serious injury, scarring, or the need for additional medical treatment. The manufacturer has received reports of patient burns associated with the use of these specific return electrodes.

What You Should Do

Identify if you have the affected product by checking the label for MEGADYNE MEGA SOFT Pediatric Patient Return Electrode, Model Number 0840, and UDI-DI 10614559103395.
Check the product packaging or device for the lot number; this recall affects all distributed lot numbers for Model 0840.
Contact your healthcare provider or Megadyne Medical Products, Inc. at 1-800-252-2818 or through their website for specific instructions on how to handle affected units and to discuss potential refunds or replacements.
If you are a healthcare professional, follow the instructions provided in the firm's notification letter regarding the continued use or return of these devices.
For additional questions or to report an injury, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

manufacturer or healthcare provider Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode (66cm x 30.5cm x 1.25cm)

Model / REF:

0840

UDI-DI: 10614559103395

Lot Numbers:

All distributed lot numbers

Product Images

“Image of packaging for Megadyne Pediatric Patient Return Electrode”

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94544

Status: Active

Manufacturer: Megadyne Medical Products, Inc.

Sold By: hospitals; surgical centers; medical distributors

Manufactured In: United States

Units Affected: 1270

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 you have the affected product by checking the label for MEGADYNE MEGA SOFT Pediatric Patient Return Electrode, Model Number 0840, and UDI-DI 10614559103395.

Check the product packaging or device for the lot number; this recall affects all distributed lot numbers for Model 0840.

Contact your healthcare provider or Megadyne Medical Products, Inc. at 1-800-252-2818 or through their website for specific instructions on how to handle affected units and to discuss potential refunds or replacements.

If you are a healthcare professional, follow the instructions provided in the firm's notification letter regarding the continued use or return of these devices.

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