Device recall: MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery

Class I FDA enforcement event 92409. Recall start date: 1 Jun 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Firm has received reports of patient burns in surgical procedures where device was used.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Megadyne Medical Products, Inc. started this device recall on 1 Jun 2023. The firm address in the FDA record is in Blue Ash, OH. FDA put the recall in Class I. FDA event 92409 has 8 product records. The first FDA enforcement report date is 5 Jul 2023. The record gives the status Ongoing.

FDA enforcement report The 8 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Distributed US Nationwide.

Recalling firm

Megadyne Medical Products, Inc., Blue Ash, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

8 product records in the event.

FDA event 92409: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1994-2023	MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery	21,100 units	Class I	Ongoing	5 Jul 2023
Z-1995-2023	MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery	21,100 units	Class I	Ongoing	5 Jul 2023
Z-1996-2023	MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery	21,100 units	Class I	Ongoing	5 Jul 2023
Z-1997-2023	MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery	21,100 units	Class I	Ongoing	5 Jul 2023
Z-1998-2023	MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery	21,100 units	Class I	Ongoing	5 Jul 2023
Z-1999-2023	MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery	21,100 units	Class I	Ongoing	5 Jul 2023
Z-2000-2023	MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery	21,100 units	Class I	Ongoing	5 Jul 2023
Z-2001-2023	MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery	21,100 units	Class I	Ongoing	5 Jul 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class I: 10%
Product records in this event: 8Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Megadyne Medical Products, Inc.
Initiated	Product (first record)	Type	Class	Records
17 Jun 2024	Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Mo	Device	Class I	3
8 May 2024	MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50	Device	Class I	1
8 Dec 2023	Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode	Device	Class I	4
15 Jun 2023	MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product	Device	Class II	1
15 May 2018	MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715	Device	Class II	1
27 Feb 2014	Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Ty	Device	Class II	1
7 Aug 2013	E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Steri	Device	Class II	1

Megadyne Medical Products, Inc.: all 8 events

Official channels

FDA enforcement report Z-1994-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 92409. https://recallregister.com/fda/i/92409/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distributed US Nationwide.
What quantity of product is in FDA event 92409?: The event has 8 product records. The first record gives this quantity: 21,100 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 10% of the 917 device events that started in 2023 are in Class I.