Is this your brand? Sign in to claim ownership.

Megadyne Medical Products, Inc.

United States·US-MF-000017046

Last updated September 17, 2026

What Megadyne Medical Products, Inc. makes

Megadyne Medical Products, Inc. manufactures single-use and reusable electrosurgical devices, including monopolar handpieces, electrodes for open and endoscopic surgery, and electrosurgical return electrodes. The company also produces surgical plume evacuation systems and their associated filters, designed to manage smoke and debris during procedures.

The portfolio includes devices classified as Class I, Class II, and Class IIb under regulatory frameworks, with listings in the EU’s eudamed registry, the FDA’s 510(k) database, and the FDA’s Unique Device Identifier (UDI) system. The company is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Megadyne Medical Products, Inc. manufacture?

Megadyne Medical Products, Inc. specializes in electrosurgical devices, including single-use and reusable products. Their portfolio covers monopolar handpieces and electrodes for both open and endoscopic surgery, as well as electrosurgical return electrodes. Additionally, they produce surgical plume evacuation systems and their associated filters, which help manage smoke and debris during procedures. These devices are designed for use in surgical settings to enhance precision and safety during procedures.

Where is Megadyne Medical Products, Inc. based?

Megadyne Medical Products, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. FDA guidelines and may also comply with international standards like those in the EU, where its devices are listed in eudamed.

Which regulatory registries list Megadyne Medical Products, Inc.’s devices?

Megadyne Medical Products, Inc.’s devices are listed in multiple regulatory databases, including the EU’s eudamed registry, the FDA’s 510(k) database for premarket notifications, and the FDA’s Unique Device Identifier (UDI) system. These registries help track and verify the authorization status of individual devices, ensuring transparency for healthcare providers and regulators.

How are Megadyne Medical Products, Inc.’s devices classified under regulatory frameworks?

Megadyne Medical Products, Inc.’s devices fall into different regulatory classes depending on their risk and intended use. Their portfolio includes Class I (low-risk), Class II (moderate-risk), and Class IIb (higher-risk) devices. Classification determines the regulatory scrutiny and requirements for authorization, with Class IIb devices typically requiring more rigorous evaluation due to their higher risk potential.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 4545, Creek Road, Cincinnati, United States
Website: its.jnj.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Sharon Sussex
EUDAMED SRN: US-MF-000017046
FDA FEI Number: 1721194
DUNS Number: —

Catalogue (446)

Page 2 of 9

Device	Model / Reference	Registries	Class	Status
Megadyne	6020096-02	FDA UDI	Class II	Unknown
Megadyne	0855CL	FDA UDI	Class II	Active
Megadyne	1300SJ	EUDAMEDFDA UDI	Class II	Active
Megadyne	0039BN	FDA UDI	Class II	Unknown
Megadyne	6020088-03	FDA UDI	Class II	Unknown
Megadyne	3030HL	FDA UDI	Class II	Unknown
Megadyne	3110-10	FDA UDI	Class II	Unknown
Megadyne	4005BN	FDA UDI	Class II	Unknown
Megadyne	0080	FDA UDI	Class II	Unknown
Megadyne	ME725M1C	EUDAMEDFDA UDI	Class II	Active
Megadyne	6020162-01	FDA UDI	Class II	Unknown
Megadyne	0014MBN	FDA UDI	Class II	Unknown
Megadyne	ME725M1E	FDA UDI	Class II	Active
Megadyne	3035HL	FDA UDI	Class II	Unknown
Megadyne	0030BN	FDA UDI	Class II	Unknown
Megadyne	ACE12AM	FDA UDI	Class II	Unknown
Megadyne	0019L	EUDAMEDFDA UDI	Class II	Active
Megadyne	0041-25	FDA UDI	Class II	Unknown
Megadyne	4020	FDA UDI	Class II	Unknown
Mega Soft	0835S	FDA UDI	Class II	Active
Megadyne	0036HBN	FDA UDI	Class II	Unknown
Megadyne	4040	FDA UDI	Class II	Unknown
Megadyne	C012ABN	FDA UDI	Class II	Unknown
Megadyne	0030HGBN	FDA UDI	Class II	Unknown
Megadyne	0037BN	FDA UDI	Class II	Unknown
Megadyne	1920	FDA UDI	Class II	Unknown
Megadyne	ACE12M	FDA UDI	Class II	Unknown
Megadyne	3020SA	FDA UDI	Class II	Unknown
Megadyne	004010J	FDA UDI	Class II	Active
Megadyne	4010	FDA UDI	Class II	Unknown
Mega Soft	0830S	FDA UDI	Class II	Active
Megadyne	3018A	FDA UDI	Class II	Unknown
Megadyne	3019SA	FDA UDI	Class II	Unknown
Megadyne	6020098-01	FDA UDI	Class II	Unknown
ZIP Pen	2540	FDA UDI	Class II	Unknown
Mini Vac	ECVV220	FDA UDI	Class II	Unknown
Megadyne	6020170-02	FDA UDI	Class II	Unknown
Megadyne	0012AP	FDA UDI	Class II	Unknown
Mega Soft	M2K-05	FDA UDI	Class II	Unknown
Megadyne	251015BN	FDA UDI	Class II	Unknown
Megadyne	0042-25	FDA UDI	Class II	Unknown
Megadyne	1900	FDA UDI	Class II	Unknown
Megadyne	0036	FDA UDI	Class II	Active
Megadyne	0040-10	FDA UDI	Class II	Unknown
Mega Vac Footswitch	2160J	FDA UDI	Class II	Unknown
Megadyne	0013BN	FDA UDI	Class II	Unknown
Megadyne	3019A	FDA UDI	Class II	Unknown
Megadyne	0028	EUDAMEDFDA UDI	Class II	Active
Megadyne	2525-10BN	FDA UDI	Class II	Unknown
Megadyne	0038HBN	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

Johnson & Johnson Medical GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (31)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Megadyne Medical Products, Inc. has 31 recall records spanning from December 20, 2002, to June 17, 2024. The recalls include open, classified, and terminated statuses, with reasons involving device malfunctions such as incorrect activation of multiple devices, potential insulation breaches, fluid ingress causing intermittent activation, incorrect expiration dates on labels, and packaging issues that may compromise sterility. Some recalls address patient burn risks linked to device use, including specific age restrictions for certain products and reports of burns during surgical procedures.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 17, 2024	Z-2250-2024	—	open, classified	To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Jun 17, 2024	Z-2249-2024	—	open, classified	To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Jun 17, 2024	Z-2248-2024	—	open, classified	To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
May 8, 2024	Z-1920-2024	—	open, classified	Reports of patient burns.
Dec 8, 2023	Z-0600-2024	—	open, classified	Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Dec 8, 2023	Z-0598-2024	—	open, classified	Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Dec 8, 2023	Z-0599-2024	—	open, classified	Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Dec 8, 2023	Z-0597-2024	—	open, classified	Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Jun 15, 2023	Z-2257-2023	—	open, classified	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).
Jun 1, 2023	Z-1998-2023	—	open, classified	Firm has received reports of patient burns in surgical procedures where device was used.
Jun 1, 2023	Z-2000-2023	—	open, classified	Firm has received reports of patient burns in surgical procedures where device was used.
Jun 1, 2023	Z-1995-2023	—	open, classified	Firm has received reports of patient burns in surgical procedures where device was used.
Jun 1, 2023	Z-1999-2023	—	open, classified	Firm has received reports of patient burns in surgical procedures where device was used.
Jun 1, 2023	Z-1994-2023	—	open, classified	Firm has received reports of patient burns in surgical procedures where device was used.
Jun 1, 2023	Z-1997-2023	—	open, classified	Firm has received reports of patient burns in surgical procedures where device was used.
Jun 1, 2023	Z-2001-2023	—	open, classified	Firm has received reports of patient burns in surgical procedures where device was used.
Jun 1, 2023	Z-1996-2023	—	open, classified	Firm has received reports of patient burns in surgical procedures where device was used.
May 15, 2018	Z-2792-2018	—	terminated	If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
Feb 27, 2014	Z-1151-2014	—	terminated	Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
Aug 7, 2013	Z-2097-2013	—	terminated	Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.
Oct 13, 2009	Z-0486-2010	—	terminated	Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.
Apr 6, 2006	Z-0781-06	—	terminated	Surgical device packaging may be damaged and may compromise sterility.
Apr 6, 2006	Z-0780-06	—	terminated	Surgical device packaging may be damaged and may compromise sterility.
Apr 6, 2006	Z-0785-06	—	terminated	Surgical device packaging may be damaged and may compromise sterility.
Apr 6, 2006	Z-0783-06	—	terminated	Surgical device packaging may be damaged and may compromise sterility.
Apr 6, 2006	Z-0779-06	—	terminated	Surgical device packaging may be damaged and may compromise sterility.
Apr 6, 2006	Z-0782-06	—	terminated	Surgical device packaging may be damaged and may compromise sterility.
Apr 6, 2006	Z-0778-06	—	terminated	Surgical device packaging may be damaged and may compromise sterility.
Apr 6, 2006	Z-0784-06	—	terminated	Surgical device packaging may be damaged and may compromise sterility.
Dec 20, 2002	Z-0469-03	—	terminated	The metal substrate cautery tip may break during use.
Dec 20, 2002	Z-0468-03	—	terminated	The metal substrate cautery tip may break during use.