FDA Issues 'Most Serious' Type Of Recall Over J&J Surgical Tools, That Could Kill Patients


By Emily Joshu

Johnson & Johnson manufactured tools used make incisions and stop bleeding during surgery have been recalled nationwide for increased risk of injury and death.

The Food and Drug Administration (FDA) said in a statement that it received reports of children and adult patients suffering burn injuries when the tools were used on them.

The agency classified the recall on Tuesday as 'most serious.'

The tools, which were sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient Electrodes, were recalled by Utah-based Megadyne Medical Products, which was acquired in 2017 by Ethicon Endo-Surgery, a unit of Johnson & Johnson MedTech.

The company received reports of 63 injuries and no deaths related to the devices and is continuing to reevaluate the root cause for patient burns.

These tools are soft pads that conduct an electric current and heat the skin. They're to make incisions and stop bleeding during surgery.

Johnson & Johnson is just one company that manufacturers these tools, which are commonly used in a variety of surgeries.

An investigation found that in some cases, the tools were used incorrectly, J&J MedTech said.

Last month, the manufacturer recalled 21,200 units of the tools, which were distributed between March 11, 2021, and May 9, 2023.

J&J MedTech also said the products are still available and it has issued notices in June to health care professionals to follow proper instructions for use.

It's unclear how severe the burn injuries were and how exactly the burns occurred.


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