U.S. FDA classifies recall of J&J's electrosurgical tools as most serious

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U.S. FDA classifies recall of J&J's electrosurgical tools as most serious
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The U.S. Food and Drug Administration (FDA) on Tuesday classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson unit as the most serious, saying their use could lead to injuries or death.

Johnson & Johnson company offices are shown in Irvine, California, U.S., October 14, 2020. REUTERS/Mike BlakeJuly 11 - The U.S. Food and Drug Administration on Tuesday classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson unitThe U.S.

The tools are soft pads that conduct an electric current through the patient's body during electrosurgical procedures to heat or cut tissue, or stop bleeding.by Ethicon Endo-Surgery Inc, a unit of J&J MedTech.Megadyne received reports of 63 injuries and no deaths related to the use of the devices and is continuing to evaluate the root cause for patient burns, the FDA said in a statement.

The regulator said Megadyne, in June 2023, initiated a recall of 21,200 units of the electrosurgery tools, distributed between March 11, 2021 and May 9, 2023.

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