Megadyne recalls MEGA SOFT Dual Reusable Patient Return Electrodes for patients under 12 due to burn risk. Affected units have model 0835; use only for patients 12+ to prevent injury.
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 SOFT Dual Reusable Patient Return Electrodes because they can cause burns in patients under 12. The recall is limited to patients aged 12 or older to reduce this risk.
The electrodes can cause burns when used on patients under 12 years old. The risk is due to the electrodes' design and the patient's age, which affects how the electrical current is distributed.
Patients using these electrodes for medical purposes. Children under 12 are at risk of burns if the electrodes are used on them.
Look for the model number 0835 on the product. These electrodes are for patients weighing over 25lbs (11.4kg) and are sold as reusable patient return electrodes.
Only use these electrodes on patients aged 12 or older to prevent burns.
To limit use to patients aged 12 or older to reduce the risk of burns.
Yes, patients under 12 are at risk of burns if the electrodes are used on them.
The model number is 0835.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-2250-2024 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-2250-2024 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.