Home / Recalls / Megadyne Medical Products, Inc. / Z-0597-2024

Z-0597-2024 Class I Ongoing

Recalled by Megadyne Medical Products, Inc. — Blue Ash, OH

FDA device recall Z-0597-2024 was initiated by Megadyne Medical Products, Inc. on December 8, 2023 and is designated Class I. Reason for recall: 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 wh… The recall status is ongoing. Affected quantity: 9,587 ea.

Recall Details

Product Type: Devices
Report Date: January 3, 2024
Initiation Date: December 8, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,587 ea

Product Description

Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode

Reason for Recall

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 Pattern

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, Lebanon, Malaysia, Martinique, Morocco, Netherlands, New Caledonia, Norway, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian , Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam

Code Information

UDI-DI 10614559103906 All units within Expiry

Other recalls by Megadyne Medical Products, Inc.

Z-2248-2024 Class I — Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYN (June 17, 2024)
Z-2250-2024 Class I — Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product (June 17, 2024)
Z-2249-2024 Class I — Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name (June 17, 2024)
Z-1920-2024 Class I — MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return E (May 8, 2024)
Z-0599-2024 Class I — Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, R (December 8, 2023)
Z-0598-2024 Class I — Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, R (December 8, 2023)
Z-0600-2024 Class I — Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electro (December 8, 2023)
Z-2257-2023 Class II — MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitc (June 15, 2023)
Z-1994-2023 Class I — MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery (June 1, 2023)
Z-2000-2023 Class I — MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during el (June 1, 2023)