May 17, 2019
By Reuters Staff
(Reuters) - The U.S. Food and Drug Administration warned of risks of serious injury or death from surgical staplers made by Johnson & Johnson's Ethicon unit, labeling a recent recall of the device as its most serious.
The recall, initiated early April by Ethicon, covers 92,496 surgical staplers and is now labeled as "Class-1" - the strictest form of recall issued by FDA, where use of faulty devices may cause serious injury or death.
J&J's Ethicon unit confirmed serious injuries to two patients, related to the use of the recalled product, the FDA said. (https://bit.ly/2Ef29CR)
The staplers, regulated as Class I medical devices that do not require a premarket submission to the FDA, are used by surgeons during gastrointestinal procedures.
The FDA will hold an advisory committee meeting on May 30 to discuss whether reclassifying the staplers for internal use as Class II medical devices would be appropriate.
The reclassification would subject the staplers to premarket notification and allow the FDA to establish further regulation on the device.(c) Copyright Thomson Reuters 2019. Click For Restrictions - https://agency.reuters.com/en/copyright.html