Blue Ash, OH, United States

Megadyne Medical Products, Inc. recalls

6 recalls recorded since 2018, most recently on 17 June 2024. 5 are listed as ongoing. Status and classification are as published by the FDA.

Recalls6

Ongoing (FDA)5

Terminated or completed1

Class I (FDA)4

Recall started: 17 June 2024
Reason: 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.
Distribution: Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2249-2024, Z-2248-2024, Z-2250-2024

Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable P
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 Elec
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description:

Recall started: 8 May 2024
Reason: Reports of patient burns.
Distribution: Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thail
Initiated: Voluntary: Firm initiated
Recall number: Z-1920-2024

MEGADYNE 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.

Recall started: 8 December 2023
Reason: 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.
Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0600-2024, Z-0599-2024, Z-0598-2024, Z-0597-2024

Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode

Recall started: 15 June 2023
Reason: 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).
Distribution: Worldwide Distributions: US (Nationwide) and OUS (Foreign) in countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, U
Initiated: Voluntary: Firm initiated
Recall number: Z-2257-2023

MEGADYNE 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

Recall started: 1 June 2023
Reason: Firm has received reports of patient burns in surgical procedures where device was used.
Distribution: Distributed US Nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2001-2023, Z-1999-2023, Z-1997-2023, Z-1994-2023, Z-1995-2023, Z-2000-2023, Z-1996-2023, Z-1998-2023

MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery
MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery

Recall started: 15 May 2018
Terminated: 30 January 2024
Reason: 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.
Distribution: Worldwide distribution. US Nationwide, Mexico, Europe, Middle East, Latin America, Africa, and Asia Pacific Markets
Initiated: Voluntary: Firm initiated
Recall number: Z-2792-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.