FDA Issues ‘Most Serious’ Recall of Johnson and Johnson Surgical Tools Linked to Patient Burns and Risks
Nationwide recall of Johnson & Johnson surgical tools due to increased risk of injury and death. The Food and Drug Administration (FDA) has categorized this recall as the ‘most serious’ type. Reports have shown burn injuries in children and adult patients resulting from the use of these tools.
The recalled tools, sold as MEGA 2000 and MEGA SOFT Reusable Patient Electrodes, were manufactured by Megadyne Medical Products. In 2017, Megadyne Medical Products was acquired 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
Megadyne Medical Products has reported 63 injuries related to the faulty tools, but no deaths. They are currently investigating the root cause of these burn injuries. It is important to note that Johnson & Johnson is not the sole manufacturer of these tools, as they are commonly used in various surgeries.
An investigation conducted by J&J MedTech revealed instances where the tools were used incorrectly. In response, the manufacturer has recalled 21,200 units of the tools distributed between March 11, 2021, and May 9, 2023. Despite the recall, the products are still available, and healthcare professionals have been reminded to follow proper instructions for use.
Further details regarding the severity and causes of the burn injuries remain unclear.
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