Megadyne recalls MEGA SOFT Universal Plus Dual Patient Return Electrodes for patients under 12 due to reported burn injuries. Affected units require medical evaluation if used on children.
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries 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.
Megadyne is recalling reusable patient return electrodes for use on patients 12 years or younger because they can cause severe burns requiring hospitalization, scarring, and additional surgeries. This risk applies to both children and adults who use the device on younger patients.
The electrode can cause burns up to third degree when used on patients under 12. These injuries may require hospitalization, scarring, and additional surgeries due to improper sizing or placement.
Patients 12 years or younger using this electrode for medical procedures are at risk. Adults using the device on children may also be affected.
Check for product code 0848 on the electrode. All units within their expiry date are affected. The product name is MEGA SOFT Universal Plus Dual Patient Return Electrode.
Do not use this electrode on patients under 12 years old. Contact your healthcare provider for alternative options.
If you have used this electrode on a patient under 12, seek medical attention immediately for potential burn injuries.
Yes, reports show third-degree burns requiring hospitalization, scarring, and additional surgeries in patients under 12.
Look for product code 0848 on the electrode. All units within their expiry date are affected.
The recall does not specify a return process, but you should stop using it on children and seek medical help if needed.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-0600-2024 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-0600-2024 from Megadyne. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
