Drugs & medicalClass I

Megadyne Medical Products, Inc. recalls Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft…

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…

Read the official notice →
Date
2024-01-03
Country
United States
Brand
Megadyne Medical Products
Product
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal…
Classification
Class I
Units
Worldwide distribution. US Nationwide including Puerto Rico; Argentina,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Megadyne Medical Products recalls

  1. 2024-07-10
  2. US
    Drugs & medicalClass I

    Megadyne Medical Products, Inc. recalls Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return…

    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.

    FDA · DeviceMegadyne Medical Products, Inc.Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN,…Official notice →
  3. 2024-06-12
  4. US
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    Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb),…

    Reports of patient burns.

    FDA · DeviceMegadyne Medical Products, Inc.Worldwide distribution. US nationwide including Puerto Rico; Australia,…Official notice →
  5. 2023-08-09
  6. US
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    Megadyne Medical Products, Inc. recalls MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code…

    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…

    FDA · DeviceMegadyne Medical Products, Inc.Worldwide Distributions: US (Nationwide) and OUS (Foreign) in countries of:…Official notice →
  7. 2023-07-05
  8. US
    Drugs & medicalClass I

    Megadyne Medical Products, Inc. recalls 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.

    FDA · DeviceMegadyne Medical Products, Inc.Distributed US Nationwide.Official notice →
All 5 Megadyne Medical Products recalls →

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    Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

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