Megadyne recalls pediatric surgery electrodes 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 all pediatric patient return electrodes used in electrosurgery after reports of patient burns. This could cause serious injury during surgery.
The electrode can cause patient burns during electrosurgery when used improperly. Reports indicate burns occurred in surgical procedures where this device was applied.
Surgical teams using Megadyne MEGA SOFT Pediatric Patient Return Electrodes during electrosurgery are affected. Patients undergoing surgery with this device are at risk of burns.
Check for the model number 0840 on the electrode. All units produced by Megadyne Medical Products, Inc. are affected.
Immediately stop using the MEGA SOFT Pediatric Patient Return Electrode if it is in your surgical equipment.
The recall applies to all units used during electrosurgery. If you have this electrode, stop using it immediately.
Look for the model number 0840 on the electrode. All units produced by Megadyne Medical Products, Inc. are affected.
Immediately stop using it. The manufacturer has not provided a replacement or repair option.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-1997-2023 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-1997-2023 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.