The Food and Drug Administration (“FDA”) oversees the regulation and safety of prescription drugs, over-the-counter drugs, and medical devices. When the FDA considers a drug or device to be in violation of its regulations and a harm to the public, it may order a recall to remove the product from the market or have the manufacturer remedy the problem.
Last week, the FDA issued a recall of certain surgical tools manufactured by Johnson & Johnson. The tools are used during surgery to make incisions and stop bleeding. The recall issued is a Class I recall, which is the FDA’s most serious type of recall.
What is a Class I recall?
Products which may cause serious injury or death are reserved for Class 1 recalls. Consequently, the FDA oversees Class I recall notification procedures to ensure their adequacy.
What are the recalled surgical tools for?
The tools are soft pads that conduct electrical currents. A pen like attachment delivers the current to the body. This aids in making incisions, cutting tissue, and stopping bleeding. The tools also contain return electric pads to enable direct contact with the skin. The return electric pads conduct heat from the skin back to the generator to reduce the risk of excessing heat and burns.
Why did the FDA issue a recall?
Th FDA received reports of children and adults suffering burns during surgery. Some of the reported burns were third degree burns requiring additional medical intervention. No deaths were reported.
What products are recalled?
Over 21,000 tools have been recalled. Recalled surgical tools include those with brand names including MEGA 2000 and MEGA Soft Reusable Patient Electrodes. Megadyne Medical Products, a subsidiary of Johnson & Johnson, manufactures the recalled tools. Megadyne Medical Products manufactured the recalled products between March 2021 and May 2023.
The manufacturer reports that hospitals still use the surgical tools. Further, it reports that it is safe to do so. However, as part of the recall process, the FDA has sent notifications alerting the medical community of the potential issues. It also sent letters to medical facilities reminding them of the importance of following product instructions.
More information about the recall can be found here. If one of these surgical tools has injured you, contact the FDA.
