Highest risk U.S. Food and Drug Administration

Megadyne Mega Soft Universal and Universal Plus Reusable Patient Return recall: Limit use to patients aged 12 years or older

Recall published 2+ years ago

Limit use to patients aged 12 years or older.

Megadyne Medical devices — recalled medical devices
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Fire or burn hazard

The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

What the notice says: These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
February 29, 2024
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Megadyne
Product type
Medical devices

Products covered by this recall

Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes

What the company announced

Cincinnati, OH – February 29, 2024 – On December 8, 2023, Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA SOFT pads were used. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged 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.

Since that notification, we have continued to monitor device performance through post market surveillance, investigated every event reported and evaluated potential root cause of these events. Megadyne recently received a report of pediatric use that included a serious 3rd degree patient burn. We are providing this additional broad public communication to increase awareness that MEGADYNE™ MEGA SOFT™ Universal and Universal Plus products should not be used for patients under the age of 12 years.

The table below contains the specific product and codes in scope. The following product codes should not be used for patients that are neonatal, infant, and children under the age of 12 years old:

  • Product Name: MEGADYNE™ MEGA SOFT™ Universal Patient Return Electrode · Product Code: 0845 · UDI-DI: 10614559103906
  • Product Name: MEGADYNE™ MEGA SOFT™ Universal Dual Patient Return Electrode · Product Code: 0846 · UDI-DI: 10614559104248
  • Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Patient Return Electrode · Product Code: 0847 · UDI-DI: 10614559104842
  • Product Name: MEGADYNE™ MEGA SOFT™ Universal Plus Dual Patient Return Electrode · Product Code: 0848 · UDI-DI: 10614559104859

What to do

Customers should review and follow the instructions provided in the December 2023 recall notification. Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes pads may continue to be used for patients over 12 years of age.

A link to the customer notification can be found here .

Confirm that personnel using the Mega Soft Universal and Universal Plus pads understand the intended use is changing to patients aged 12 years and older and have stopped using the pads on patients under the age of 12 years. Hospitals using this product should confirm receipt of the recall notification using the business reply form provided with the initial recall notification.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

If you need additional copies of the recall notification or need a business reply form, please contact Sedgwick at 888-843-0254 and reference Event # 5627.

The safe and effective use of our products is top priority. If you have additional questions regarding this communication or to report any product complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.

If medical engagement is requested, please have the Healthcare Provider submit the request using the Medical Information Request website: https://www.jnjmedtech.com/mir

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • 0845
  • 0846
  • 0847
  • 0848

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Megadyne — The hazard here is thermal: the product can get hot enough to ignite what is around it, or to burn whoever is holding it.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.
  3. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.
  4. Move it off anything that burns — a bed, a sofa, a carpet, a pile of paper — and away from exits.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.

Company contact: Megadyne Medical Products, Inc. — Consumers: Ethicon Resource Department, 1-877-ETHICON (1-877-384-4266)

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Megadyne medical devices recalled?

Limit use to patients aged 12 years or older. These reports of patient burn injuries described up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 0845, 0846, 0847. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

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