FDA issues its “most serious” type of recall on surgical tools made by Johnson & Johnson that could KILL patients, and dozens across the country have already suffered burns
Tools made by Johnson & Johnson that are used to make incisions and stop bleeding during surgery have been recalled nationwide due to 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 burns when the tools were used on them.
The agency classified the recall 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 FDA 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 reassess the root cause of patient burns.
These tools are soft pads that conduct an electrical current and heat the skin. They are to make incisions and stop bleeding during surgery.
Johnson & Johnson is just one of the companies that makes 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 issued advisories in June to healthcare professionals to follow proper instructions for use.
It is unclear how severe the burn injuries were and how exactly the burns occurred.