Recall Register

Megadyne Medical Products, Inc.: FDA recalls

FDA enforcement reports name Megadyne Medical Products, Inc. as the recalling firm in 8 events. The events have 20 product records. The recalls started from 2013 to 2024. All the events are device recalls.

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 . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Megadyne Medical Products, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
17 Jun 2024Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: NoDeviceClass I3Ongoing
8 May 2024MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.DeviceClass I1Ongoing
8 Dec 2023Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return ElectrodeDeviceClass I4Ongoing
15 Jun 2023MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator,…DeviceClass II1Ongoing
1 Jun 2023MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgeryDeviceClass I8Ongoing
15 May 2018MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715DeviceClass II1Terminated
27 Feb 2014Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general…DeviceClass II1Terminated
7 Aug 2013E-Z Clean Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

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

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

Type and class

Megadyne Medical Products, Inc.: events for each product type
TypeEvents
Device8
Megadyne Medical Products, Inc.: events in each class
ClassEvents
Class I4
Class II4
Share of the events of the firm in Class I
50%
Share of all events on the register in Class I
18%
Events with the status Ongoing
5

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.

Events by year

FDA enforcement events of Megadyne Medical Products, Inc., by the year that the recall started. The largest year is 2023, with 3 events.

Official channels

Cite this page

Recall Register. Megadyne Medical Products, Inc.: FDA recalls. https://recallregister.com/firm/megadyne-medical-products-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
OH, UT

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Megadyne Medical Products, Inc. have?
Class I: 4 events. Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Megadyne Medical Products, Inc.?
FDA event 94837, which the firm started on 17 Jun 2024. The first product in the record is: Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide Component: No
How many FDA recalls of Megadyne Medical Products, Inc. have the status Ongoing?
5 events have the status Ongoing in the openFDA file. openFDA says 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.