--- title: "Megadyne Medical Products, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Megadyne Medical Products, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/megadyne-medical-products-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Megadyne Medical Products, Inc. recall records **17** reported ongoing 19 records in this archive. Latest source date Jun 17, 2024. 2 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 17, 2024 FDA device enforcement ### [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 De...](https://isitonrecall.com/recall/fda-device-z-2248-2024-brand-name-megadyne-mega-2000-patient-return-electrode-product-name-megadyne-mega-2000-patient-retur/) 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 I Reported ongoing Distribution: Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SI... [Official source for Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Pati...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2248-2024%22) Jun 17, 2024 FDA device enforcement ### [Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Versi...](https://isitonrecall.com/recall/fda-device-z-2249-2024-brand-name-megadyne-mega-soft-reusable-patient-return-electrode-product-name-megadyne-mega-soft-reus/) 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 I Reported ongoing Distribution: Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SI... [Official source for Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA S...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2249-2024%22) Jun 17, 2024 FDA device enforcement ### [Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Soft...](https://isitonrecall.com/recall/fda-device-z-2250-2024-brand-name-megadyne-mega-soft-dual-reusable-patient-return-electrode-product-name-megadyne-mega-soft/) 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 I Reported ongoing Distribution: Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SI... [Official source for Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" M...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2250-2024%22) May 10, 2024 FDA company announcement ### [Ethicon Megadyne: Mega Soft Pediatric Patient Return Electrode](https://isitonrecall.com/recall/fdapress-f70f163eafa15607-ethicon-megadyne-mega-soft-pediatric-patient-return-electrode/) Reports of patient burn injuries Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for Ethicon Megadyne: Mega Soft Pediatric Patient Return Electrode](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadynetm-initiates-global-discontinuation-and-voluntary-recall-mega-softtm-pediatric-patient) May 8, 2024 FDA device enforcement ### [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. Ele...](https://isitonrecall.com/recall/fda-device-z-1920-2024-megadyne-mega-soft-pediatric-patient-return-electrode-reusable-patient-return-electrode-for-patients/) Reports of patient burns. Class I Reported ongoing Distribution: Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, It... [Official source for MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for pati...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1920-2024%22) Feb 29, 2024 FDA company announcement ### [Megadyne: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes](https://isitonrecall.com/recall/fdapress-e1f497ce46009c8d-megadyne-mega-soft-universal-and-universal-plus-reusable-patient-return-electrodes/) Limit use to patients aged 12 years or older. Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for Megadyne: Mega Soft Universal and Universal Plus Reusable Patient Return Electrodes](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/megadyne-reiterates-intended-use-population-change-megadyne-mega-soft-universal-and-universal-plus) Dec 8, 2023 FDA device enforcement ### [Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode](https://isitonrecall.com/recall/fda-device-z-0597-2024-product-code-0845-megadyne-mega-soft-universal-patient-return-electrode-reusable-patient-return-elec/) 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 ad... Class I Reported ongoing Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Es... [Official source for Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0597-2024%22) Dec 8, 2023 FDA device enforcement ### [Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord](https://isitonrecall.com/recall/fda-device-z-0598-2024-product-code-0846-megadyne-mega-soft-universal-dual-patient-return-electrode-reusable-patient-return/) 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 ad... Class I Reported ongoing Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Es... [Official source for Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient R...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0598-2024%22) Dec 8, 2023 FDA device enforcement ### [Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus](https://isitonrecall.com/recall/fda-device-z-0599-2024-product-code-0847-megadyne-mega-soft-universal-plus-patient-return-electrode-reusable-patient-return/) 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 ad... Class I Reported ongoing Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Es... [Official source for Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient R...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0599-2024%22) Dec 8, 2023 FDA device enforcement ### [Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus](https://isitonrecall.com/recall/fda-device-z-0600-2024-product-code-0848-megadyne-mega-soft-universal-plus-dual-patient-return-electrode-reusable-patient-r/) 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 ad... Class I Reported ongoing Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Es... [Official source for Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Pati...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0600-2024%22) Jun 15, 2023 FDA device enforcement ### [MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 i...](https://isitonrecall.com/recall/fda-device-z-2257-2023-megadyne-suction-coagulators-product-code-004125-suction-coagulator-handswitching-10-fr-6-inch-15-24/) 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 II Reported ongoing Distribution: Worldwide Distributions: US (Nationwide) and OUS (Foreign) in countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA... [Official source for MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 in...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2257-2023%22) Jun 1, 2023 FDA device enforcement ### [MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery](https://isitonrecall.com/recall/fda-device-z-1994-2023-megadyne-mega-2000-patient-return-electrode-used-during-electrosurgery/) Firm has received reports of patient burns in surgical procedures where device was used. Class I Reported ongoing Distribution: Distributed US Nationwide. [Official source for MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1994-2023%22) Jun 1, 2023 FDA device enforcement ### [MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery](https://isitonrecall.com/recall/fda-device-z-1995-2023-megadyne-mega-soft-reusable-patient-return-electrode-used-during-electrosurgery/) Firm has received reports of patient burns in surgical procedures where device was used. Class I Reported ongoing Distribution: Distributed US Nationwide. [Official source for MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1995-2023%22) Jun 1, 2023 FDA device enforcement ### [MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery](https://isitonrecall.com/recall/fda-device-z-1996-2023-megadyne-mega-soft-dual-reusable-patient-return-electrode-used-during-electrosurgery/) Firm has received reports of patient burns in surgical procedures where device was used. Class I Reported ongoing Distribution: Distributed US Nationwide. [Official source for MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1996-2023%22) Jun 1, 2023 FDA device enforcement ### [MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery](https://isitonrecall.com/recall/fda-device-z-1997-2023-megadyne-mega-soft-pediatric-patient-return-electrode-used-during-electrosurgery/) Firm has received reports of patient burns in surgical procedures where device was used. Class I Reported ongoing Distribution: Distributed US Nationwide. [Official source for MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1997-2023%22) Jun 1, 2023 FDA device enforcement ### [MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery](https://isitonrecall.com/recall/fda-device-z-1998-2023-megadyne-mega-soft-universal-patient-return-electrode-used-during-electrosurgery/) Firm has received reports of patient burns in surgical procedures where device was used. Class I Reported ongoing Distribution: Distributed US Nationwide. [Official source for MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1998-2023%22) Jun 1, 2023 FDA device enforcement ### [MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery](https://isitonrecall.com/recall/fda-device-z-1999-2023-megadyne-mega-soft-universal-plus-patient-return-electrode-used-during-electrosurgery/) Firm has received reports of patient burns in surgical procedures where device was used. Class I Reported ongoing Distribution: Distributed US Nationwide. [Official source for MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1999-2023%22) Jun 1, 2023 FDA device enforcement ### [MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery](https://isitonrecall.com/recall/fda-device-z-2000-2023-megadyne-mega-soft-universal-plus-dual-patient-return-electrode-used-during-electrosurgery/) Firm has received reports of patient burns in surgical procedures where device was used. Class I Reported ongoing Distribution: Distributed US Nationwide. [Official source for MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2000-2023%22) Jun 1, 2023 FDA device enforcement ### [MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery](https://isitonrecall.com/recall/fda-device-z-2001-2023-megadyne-mega-soft-universal-dual-patient-return-electrode-used-during-electrosurgery/) Firm has received reports of patient burns in surgical procedures where device was used. Class I Reported ongoing Distribution: Distributed US Nationwide. [Official source for MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2001-2023%22) ## Reasons in these listed records - 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. - Reports of patient burn injuries - Reports of patient burns. - Limit use to patients aged 12 years or older. These examples come from this result page and are not a ranking of every recall reason. ## Checking Megadyne Medical Products, Inc. ### Is there a recall on megadyne medical products, inc. right now? This archive contains 19 records, including 17 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Megadyne Medical Products, Inc.](https://isitonrecall.com/check/?q=Megadyne%20Medical%20Products%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)