Megadyne recalls reusable patient return electrodes for use in patients under 12 due to reported burn injuries. Affected units may cause third-degree burns requiring hospitalization.
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 that can cause burns in children under 12. Using these electrodes on patients younger than 12 may lead to serious injuries requiring hospitalization, scarring, and additional surgeries.
The electrode can cause burns when used on patients younger than 12. Reported injuries include third-degree burns requiring hospitalization, scarring, and additional surgeries.
Patients under 12 years old using these electrodes are at risk. Healthcare providers using the product for pediatric patients should be cautious.
Check for product code 0845 on the electrode. The product was sold with UDI-DI 10614559103906 and has an expiration date.
Verify the electrode's age to ensure it is not being used on patients under 12 years old.
Yes, reports show third-degree burns requiring hospitalization, scarring, and additional surgeries in patients under 12.
Look for product code 0845 with UDI-DI 10614559103906 on the electrode.
The recall does not specify a remedy, so contact Megadyne directly for guidance.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-0597-2024 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-0597-2024 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.
