Home / Recalls / Megadyne Medical Products, Inc. / Z-1920-2024

Z-1920-2024 Class I Ongoing

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

Recall Details

Product Type
Devices
Report Date
June 12, 2024
Initiation Date
May 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1270

Product Description

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.

Reason for Recall

Reports of patient burns.

Distribution Pattern

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, Thailand, United Arab Emirates, and United Kingdom.

Code Information

Model Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.

Other recalls by Megadyne Medical Products, Inc.

  • 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-2248-2024 Class I — Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYN (June 17, 2024)
  • Z-0600-2024 Class I — Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electro (December 8, 2023)
  • Z-0598-2024 Class I — Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, R (December 8, 2023)
  • Z-0597-2024 Class I — Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusab (December 8, 2023)
  • Z-0599-2024 Class I — Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, R (December 8, 2023)
  • Z-2257-2023 Class II — MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitc (June 15, 2023)
  • Z-1996-2023 Class I — MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electros (June 1, 2023)
  • Z-1998-2023 Class I — MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurge (June 1, 2023)