Facility

MEGADYNE MEDICAL PRODUCTS, INC.

8 recall(s) on record — most severe on record: Class I.

Key facts

8recalls · worst Class I

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1721194
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	4545 Creek Rd. Cincinnati, OH, US 45242
Registration status	Active · expires 2026
Parent company	Megadyne Medical Products, Inc. (owner-operator 1721194)
Brand names	Suction Coagulator

Activity by year

Recalls (8)
Inspections (2)

Devices registered here (1)

Electrosurgical, Cutting & Coagulation & Accessories
Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

Class IOngoing2024-06-17
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.
Class IOngoing2024-05-08
Reports of patient burns.
Class IOngoing2023-12-08
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 b…
Class IIOngoing2023-06-15
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).
Class IOngoing2023-06-01
Firm has received reports of patient burns in surgical procedures where device was used.
Class IITerminated2018-05-15
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.
Class IITerminated2014-02-27
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 …
Class IITerminated2013-08-07
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.

FDA inspections (2)

NAI2024-11-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2023-06-06
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Megadyne Medical Products, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MEGADYNE MEDICAL PRODUCTS, INC. (FEI 1721194) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1721194-megadyne-medical-products-inc/

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