Megadyne recalls suction coagulators with product codes 004125, 004225, 004325, and 0041BN due to potential fluid ingress causing device activation issues when used with electrosurgery units.
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
Megadyne is recalling specific suction coagulator models that may allow fluid to enter the handpiece, causing the device to activate unexpectedly or fail when connected to an electrosurgery unit. This could lead to improper surgical procedures or device malfunction during medical procedures.
Fluid can enter the handpiece of the suction coagulator, causing it to activate intermittently, not activate at all, or activate unexpectedly when plugged into an electrosurgery unit. This could lead to improper surgical procedures or device malfunction during medical procedures.
Medical professionals using Megadyne suction coagulators with product codes 004125, 004225, 004325, or 0041BN are most at risk. These devices are used during surgical procedures and may malfunction if fluid enters the handpiece.
Check for product codes 004125, 004225, 004325, or 0041BN on the device. The specific batch numbers and serial numbers are listed in the recall notice for identification.
Identify your suction coagulator model by checking the product code on the device or packaging.
If your device has a product code listed in the recall, stop using it immediately to prevent potential activation issues.
Product codes 004125, 004225, 004325, and 0041BN are affected. Each has specific batch numbers listed in the recall notice.
Fluid can enter the handpiece, causing the device to activate intermittently, not activate, or activate unexpectedly when connected to an electrosurgery unit.
The recall does not specify a return process, but affected devices should be stopped from use immediately.
We’ve drafted a message you can send Megadyne to request your refund or repair — edit it as you like.
Subject: Recall Z-2257-2023 — Megadyne Megadyne Hello, I own a Megadyne that is covered by recall Z-2257-2023 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.
