Megadyne recalls MEGA SOFT Universal Plus Dual Patient Return Electrode due to reported patient burns during electrosurgery. 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 Plus Dual Patient Return Electrode used in electrosurgery because reports indicate patient burns. This device is critical for surgical procedures and must be checked for safety.
The electrode can cause patient burns during electrosurgery when used improperly. Reports indicate burns occurred in surgical procedures, but the exact cause is not specified.
Surgical staff and patients using this electrode during electrosurgery are affected. Patients at risk are those undergoing procedures where this device is used.
Check for the model number 0848 on the device. All units of this electrode are affected, regardless of when or where it was sold.
Look for the model number 0848 on the electrode to confirm it is recalled.
The recall reports patient burns during surgery, so it is not safe to use without checking for the model number 0848.
Check for the model number 0848 on the electrode. All units are affected.
The recall does not specify a stop-use instruction, but you should check the model number before use.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-2000-2023 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-2000-2023 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.
