FDA Medical Device Recalls (openFDA)
Megadyne Medical Products, Inc.: MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
- Recall number
- Z-1995-2023
- Recalling firm
- Megadyne Medical Products, Inc.
- Product
- MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
- Status
- Open, Classified
- Initiated
- 2023-06-01
- Posted
- 2023-06-30
- Terminated
- not on file
- Reason
- Firm has received reports of patient burns in surgical procedures where device was used.
- Root cause
- Under Investigation by firm
- Action
- The firm distributed a recall notification by mail starting 06/01/2023. Customers are to provide the notice to all users of MEGADYNE MEGA SOFT and MEGA 2000 Reusable Patient Return Electrodes that participate in the cleaning, setup, and operation of affected devices. Megadyne has been made aware of 63 reports of serious patient burns since April 2018. The firm has attributed the incidence of burns to some instances that the Mega Soft Pad Instructions For Use were not being properly followed. Devices must be thoroughly rinsed after cleaning to ensure any cleaning residue is removed. Customers are asked to distribute the recall notification to all users, confirm that personnel are following the Instructions For Use, and post the provided informational attachments near the OR for staff member reference. If devices have been further distributed customers are to share the provided recall notice. Completed Business Reply Forms are to be faxed to Sedgwich at 888-214-7430 or emailed Ethicon5627@sedgwick.com. Any questions about the Business Reply Form can be made by phone to 888-843-0254 (Reference Event 5627). Any questions about this recall or to report a complaint can be made by phone to 1-877-384-4266, Monday thru Friday from 8:00 AM to 5:00 PM. Medical Engagement can be requested at https://www.jnjmedtech.com/mir.
- Quantity
- 21,100 units
- Distribution
- Distributed US Nationwide.
- Lot, serial or model codes
- Model No. 0830; UDI-DI: 10614559101797; All Units.
- 510(k) numbers
- ["K021077"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1721194
- Firm city
- Blue Ash
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28