Megadyne recalls MEGA SOFT Universal Dual Patient Return Electrodes used in electrosurgery due to reported patient burns. All units are affected.
Firm has received reports of patient burns in surgical procedures where device was used.
Megadyne is recalling its MEGA SOFT Universal Dual Patient Return Electrodes used in electrosurgery because they've caused patient burns during surgical procedures. This recall affects all units of the product.
The electrode can cause patient burns during electrosurgery when used improperly. Reports indicate burns occurred in surgical procedures where this device was applied.
Surgical staff and patients who use this electrode during electrosurgery are affected. Patients at risk are those undergoing procedures where this device is used.
Check for the model number 0846 on the electrode. All units of this product are affected, regardless of when or where it was sold.
Look for the model number 0846 on the electrode to confirm it is recalled.
The recall record does not mention any remedy or fix for this product.
Check for the model number 0846 on the electrode. All units of this product are affected.
The recall reports patient burns in surgical procedures where this device was used, indicating a risk of injury.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-2001-2023 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-2001-2023 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.
