Megadyne recalls MEGA 2000 Patient Return Electrodes for patients under 12 due to burn risk. This device is for adults weighing over 25lbs; children under 12 may experience burns if used.
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Megadyne is recalling its MEGA 2000 Patient Return Electrodes because they can cause burns in patients under 12. The device is intended for adults weighing over 25 pounds, so children under 12 should not use it.
The Mega Soft pads can cause burns in patients under 12 due to improper sizing. The device is intended for adults weighing over 25 pounds, so children under 12 may not fit correctly, increasing burn risk.
Patients under 12 years old who use this electrode for medical purposes are at risk of burns. The device is designed for adults weighing over 25 pounds.
Check for the product name 'MEGADYNE MEGA 2000 Patient Return Electrode' with model number 0800. The device is for patients weighing over 25 pounds and is reusable.
Ensure the patient is 12 years or older before using the electrode.
No, this electrode is designed for patients 12 years or older. Children under 12 may experience burns if used.
The model number is 0800.
Only if the patient is 12 years or older. Otherwise, do not use it.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-2248-2024 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-2248-2024 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.
