Megadyne recalls MEGA SOFT Universal 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 its MEGA SOFT Universal Dual Patient Return Electrodes because they can cause serious burns in patients under 12 years old. Using these electrodes on children may lead to third-degree burns requiring hospitalization, scarring, and additional surgeries.
The electrodes can cause burns when used on children under 12 because their skin is thinner and more sensitive. Reports show injuries ranging from mild to severe, including third-degree burns that may require hospitalization, scarring, and additional surgeries.
Patients under 12 years old using the recalled electrodes are at risk. Pediatric patients are most vulnerable due to the size and sensitivity of their skin.
Check for product code 0846 on the electrode. The product was sold with UDI-DI 10614559104248 and all units within expiry date.
Look for product code 0846 on the electrode to confirm if it's affected.
Reach out to Megadyne Medical Products for guidance on next steps if you have the recalled product.
Yes, reports show third-degree burns requiring hospitalization, scarring, and additional surgeries in patients under 12.
Check for product code 0846 on the electrode. The product was sold with UDI-DI 10614559104248 and all units within expiry date.
Contact Megadyne Medical Products for guidance on next steps if you have the recalled product.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-0598-2024 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-0598-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
