FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake
(Reuters) – The U.S. Food and Drug Administration on Friday issued a recall of surgical staplers made by Johnson & Johnson’s Ethicon unit, warning that the use of the devices could cause serious injury or death.
In March, Ethicon unit released a notice warning of issues with its Intraluminal Staplers.
The Class-1 recall will cover 92,496 Endo-surgery intraluminal staplers. The staplers being recalled are used by surgeons during procedures in the gastrointestinal tract.
A Class 1 recall is the strictest form of recall issued by the health regulator, 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 affected product, the FDA said.
Misfiring of the stapler had led to extra resections, or surgical removal, of the middle rectum in one patient and the lower rectum in another, the FDA said.
Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Shailesh Kuber