ETHICON ER60BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036040811), received between Oct 23, 2025 and May 4, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Separation Problem

  IT WAS REPORTED THAT PREOPERATIVELY TO UNSPECIFIED SURGICAL PROCEDURE, WHEN THE TECH REMOVED THE RELOAD, THE SILVER BACKING STAYED IN THE ETHICON 4000 STAPLER. THEY DISCOVERED THIS WHEN THEY WENT TO RELOAD THE STAPLER, AND THE RELOAD WOULD NOT SNAP DOWN. THIS WAS WITH A BLUE RELOAD. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072526 ↗
• MalfunctionApr 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027487 ↗
• MalfunctionMar 19, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A ROUX-EN-Y PROCEDURE, THE SURGEON FIRED THE STAPLE LOAD ACROSS THE SMALL INTESTINE, AND MAJORITY OF THE STAPLES WERE FIRED, HOWEVER THIS ONE WAS ESSENTIALLY FIRED VERTICALLY IN A STRAIGHT LINE LOOKING LIKE A WIRE WHICH LOOKS VERY MALFORMED WHERE IT COULD HAVE PERFORATED AN ORGAN OR VESSEL. THAT STAPLE LOAD FIRED APPROPRIATELY OUTSIDE FROM THIS STAPLE LINE WAS HEMOSTATIC AND SATISFACTORY. BUT THE CONCERN LIES WITH THE MALFORMED SHAPES OF THE STAPLES. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639365 ↗
• MalfunctionJan 28, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, THEY NOTICED SOME BLUE FRAGMENTS ON THE SPECIMEN SIDE ON THE SECOND TO LAST FIRING. THEY LOOKED LIKE BLUE RELOAD PIECES ON THAT SIDE. THEY WERE USING THE ETHICON 4000 STAPLER AND IT WAS A BLUE RELOAD. THERE WERE NO BLUE FRAGMENTS FOUND ON THE PATIENT SIDE AND THE STAPLE LINE LOOKED GOOD. THE RELOAD LOOKED FRAYED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200641 ↗
• InjuryOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A BARIATRIC REVISION, THE SURGEON FIRED THE STAPLER LAPAROSCOPICALLY AND USED GORE SEAMGUARD, SHORTLY AFTER THE SURGEON HAD TO OPEN THE PATIENT, GRASP THE STOMACH AND STAPLE LINE, AND A STAPLE SNAGGED HER GLOVE, PUNCTURING IT AND HER FINGER. THE STAPLE WAS RETRIEVED FROM HER FINGER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373121 ↗