The Recall Desk

FDA (Devices) recall action 93597

Megadyne Medical Products, Inc. recalled 4 products on 2024-01-03

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2024-01-03
Critical
3
Units
15,471

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • CriticalFDA (Devices)··2024-01-03

    Megadyne Patient Return Electrode Recalled Due to Serious Burn Injury Reports

    Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.

    Product
    Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
    Category
    Distribution
    1 state
  • CriticalFDA (Devices)··2024-01-03

    Megadyne MEGA SOFT Return Electrode Recalled for Serious Burn Injuries

    Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.

    Product
    Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2024-01-03

    Megadyne Patient Return Electrodes Recalled Due to Serious Burn Risk

    Megadyne Medical Products recalls its MEGA SOFT Universal Dual Patient Return Electrode due to reports of severe burn injuries, including third-degree burns requiring medical intervention. Use is now restricted to patients age 12 and older.

    Product
    Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
    Category
    Distribution
    1 state
  • CriticalFDA (Devices)··2024-01-03

    MEGADYNE MEGA SOFT Return Electrode Recalled Due to Reported Patient Burn Injuries

    Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in patients age 12 and older.

    Product
    Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
    Category
    Distribution
    1 state