Megadyne recalls reusable patient return electrodes for use in patients 12+ due to burn risks. Third-degree burns reported in children and adults may require hospitalization and surgery.
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 patients under 12. Using these electrodes on children 12 years or younger may lead to serious injuries requiring hospitalization and additional surgeries.
The electrode can cause burns up to third degree when used on children 12 years or younger. These burns may require hospitalization, additional surgeries, and cause scarring.
Patients 12 years or younger using these electrodes are at risk. Pediatric patients are most vulnerable due to higher burn risk.
Check for product code 0847 on the electrode. All units have an expiration date.
Only use this electrode on patients 12 years or older. Do not use on children under 12.
Yes, reports show third-degree burns requiring hospitalization and additional surgeries in patients under 12.
Look for product code 0847 on the electrode. All units have an expiration date.
The recall does not provide a fix; the remedy is not stated in the record.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-0599-2024 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-0599-2024 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.
