Z-2001-2023Class I

MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery

Name: Z-2001-2023 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Creator: Megadyne Medical Products, Inc.
Published: 2023-06-01
License: https://open.fda.gov/license/

Megadyne Medical Products, Inc / initiated 2023-06-01 / Open, Classified

FDA source

Megadyne Medical Products, Inc. began a recall of MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery on 2023-06-01. FDA classified it as Class I and gives the reason as "Firm has received reports of patient burns in surgical procedures where device was used". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2001-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-06-01
Posted: 2023-06-30
Recalling firm: Megadyne Medical Products, Inc
Product: MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Firm has received reports of patient burns in surgical procedures where device was used.
FDA 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 [email protected]. 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 in commerce: 21,100 units
Distribution: Distributed US Nationwide.
Product codes and lots: Model No. 0846; UDI-DI: 10614559104248; All Units.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2001-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1994-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29
Z-1995-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29
Z-1996-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29
Z-1997-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29
Z-1998-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29
Z-1999-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29
Z-2000-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29
Z-2001-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29

Product code GEI

K133726Class IIMega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc. / cleared 2014-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)