Home / Recalls / Megadyne Medical Products, Inc. / Z-1998-2023

Z-1998-2023 Class I Ongoing

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

Recall Details

Product Type
Devices
Report Date
July 5, 2023
Initiation Date
June 1, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21,100 units

Product Description

MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery

Reason for Recall

Firm has received reports of patient burns in surgical procedures where device was used.

Distribution Pattern

Distributed US Nationwide.

Code Information

Model No. 0845; UDI-DI: 10614559103906; All Units.

Other recalls by Megadyne Medical Products, Inc.

  • Z-2249-2024 Class I — Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name (June 17, 2024)
  • Z-2250-2024 Class I — Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product (June 17, 2024)
  • Z-2248-2024 Class I — Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYN (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-0597-2024 Class I — Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusab (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-1997-2023 Class I — MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurge (June 1, 2023)