Mega Soft M2K09Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10614559105252), received between Apr 1, 2024 and Apr 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K080741, K133726); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CABLE SENT IS A CABLE WITH ANOTHER CODE. CUSTOMER STATES THAT THIS CABLE SENT HAS THE CABLE LABEL , HOWEVER THE CONTENT IS ANOTHER CODE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014489 ↗
• MalfunctionApr 1, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CABLE SENT IS A CABLE WITH ANOTHER CODE. CUSTOMER STATES THAT THIS CABLE SENT HAS THE CABLE LABEL , HOWEVER THE CONTENT IS ANOTHER CODE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014464 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080741, K133726. One submission often covers many models, so check the product and lot details in each record.

• Z-2248-2024 · Jun 17, 2024 · Open, Classified
  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 Descr
• Z-1920-2024 · May 8, 2024 · Open, Classified
  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. Electr
• Z-0597-2024 · Dec 8, 2023 · Open, Classified
  Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
• Z-2000-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
• Z-2001-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
• Z-1998-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
• Z-1999-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
• Z-1997-2023 · Jun 1, 2023 · Open, Classified
  MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery