FDA issues ‘most serious’ recall over surgical tools from Johnson & Johnson that could KILL patients

FDA issues its ‘most serious’ type of recall for surgical instruments made by Johnson and Johnson that could KILL patients – and dozens across the country have already suffered burns

Johnson & Johnson-manufactured tools used to make incisions and stop bleeding during surgery have been recalled across the country due to an increased risk of injury and death.

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

The agency classified the recall as “most serious” on Tuesday.

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 division of Johnson & Johnson MedTech.

The FDA has issued a recall of more than 21,000 surgical tools used to make incisions and stop bleeding

The company received reports of 63 injuries and no deaths related to the devices and continues to re-evaluate the cause of patient burns.

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

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

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

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

J&J MedTech also said the products are still available and issued notices in June to healthcare professionals to follow proper usage instructions.

It is unclear how serious the burns were and how exactly the burns started.