The FDA classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson (NYSE: JNJ) unit as the most serious, saying their use could lead to injuries or death.
Megadyne is recalling MEGA 2000 and MEGA SOFT reusable patient return electrodes after receiving reports of patients receiving burn injuries from use in both pediatric and adult patients. Diathermy Device
These burns may be as serious as third-degree burns requiring medical intervention and may lead to a longer hospital stay, scarring, and potentially more surgeries for pediatric and adult patients.
Megadyne is continuing to evaluate the root cause for patient burns. The use of affected products may cause serious injury or death.
Megadyne reports 63 injuries and no deaths related to this issue.
The tools are soft pads that conduct an electric current through the patient's body during electrosurgical procedures to heat, cut tissue, or stop bleeding.
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.
Price Action: JNJ shares are down 0.76% at $158.31 on the last check Tuesday.
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This article Johnson & Johnson's Unit Recalls Certain Electrosurgical Tools Due Risk Of Burn Injuries originally appeared on Benzinga.com
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