The U.S. Food and Drug Administration labeled a recall of surgical staplers by Johnson & Johnson's medical device subsidiary Ethicon as a class I recall, the most serious classification.
The recall was issued April 11 by Ethicon and covers two of the company's curved intraluminal surgical stapler products, according to a May 16 statement from the FDA. Continued use of the devices covered by the class I recall could result in "serious injuries or death," according to the agency.
Ethicon found through investigations and returned products that washers in the stapler would go uncut and staplers would be damaged during use, resulting in the "insufficient" firing of staples. The company reported that two patients were seriously injured due to staplers misfiring, according to the statement. Ethicon attributed the malfunctions to a failure in a manufacturing line, according to the FDA.
Ann Leibson, a spokesperson for Ethicon, told S&P Global Market Intelligence in an emailed statement that Ethicon voluntarily issued the recall and has notified its customers.
The FDA has recently cracked down on medical device safety, with a specific focus on surgical staplers. The FDA proposed reclassifying surgical staplers for internal use from a class I medical device to a class II device on April 23. The reclassification would require a premarket review process and stricter safety standards.
The agency also sent a letter to healthcare providers on March 8 warning them of the risks associated with surgical staplers and staples. The FDA received over 41,000 medical device reports for surgical staplers and staples for internal use between Jan. 1, 2011, and March 31, 2018, including 32,000 reports of malfunctions, 9,000 reports of serious injuries and 366 reports of death, according to the agency's letter.
A public meeting will be held May 30 and May 31, during which a panel of experts will review the overall safety of the devices and review data the agency has collected. The FDA will present a comprehensive analysis of all the medical-device reports the agency has received regarding the internal use of surgical staplers and staples.