Megadyne recalls reusable surgical electrodes due to reported patient burns during electrosurgery. All units are affected; contact for remedy.
Firm has received reports of patient burns in surgical procedures where device was used.
Megadyne is recalling all reusable MEGA SOFT patient return electrodes used in electrosurgery after reports of patient burns. This could cause serious injury during surgery if the device malfunctions.
The electrode can cause patient burns during electrosurgery if it malfunctions. Reports indicate this has happened in real surgical procedures.
Surgical staff and patients using Megadyne MEGA SOFT electrodes during electrosurgery. Those with the model number 0830 are most at risk.
Check for the model number 0830 on the electrode. All units are affected, so no specific purchase date or location is needed.
Immediately stop using the MEGA SOFT electrode if it is part of your surgical equipment.
The recall record does not mention any remedy or fix.
Look for the model number 0830 on the electrode. All units are affected.
Yes, reports indicate patient burns during surgical procedures using this electrode.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-1995-2023 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-1995-2023 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.
