ETHICON EC3D60LRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705036043546), received between Oct 21, 2025 and Aug 25, 2026 — classified as 6 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (13 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Positioning Failure; Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50433643 ↗
• MalfunctionAug 14, 2026Failure to Fire; Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254171 ↗
• MalfunctionJul 31, 2026Positioning Failure; Self-Activation or Keying; Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104521 ↗
• MalfunctionJul 27, 2026Failure to Form Staple; Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019029 ↗
• MalfunctionJun 23, 2026Positioning Failure; Mechanical Jam; Firing Problem

  IT WAS REPORTED THAT DURING A LAP GASTRIC SLEEVE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE FIRED A LITTLE SLOWER THAN NORMAL, AND AFTER IT FIRED AND RETRACTED THE KNIFE BLADE, CUSTOMER REPORTED HITTING THE HOME BUTTON AND THE DEVICE JAWS NOT RETURNING TO HOME POSITION. THEY TOOK OUT BATTERY AND REINSERTED BATTERY, THE HOME BUTTON DID NOT RETURN TO HOME. THEY HAD TO REMOVE THE TROCAR TO GET THE DEVICE OUT AS IT WAS STILL ARTICULATED. PROCEDURE WAS DELAYED BY 10 MINUTES DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593286 ↗
• MalfunctionJun 22, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS USING A ENDOSCOPIC STAPLER AND WHILE THE STAPLE LOAD WAS FIRING THE HOME FUNCTION WAS AUTOMATICALLY ACTIVATING CAUSING THE STAPLER TO RESET TO HOME POSITION WHILE ACTIVELY FIRING LOAD. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25585102 ↗
• MalfunctionJun 18, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE INVOLVING CREATION OF A J-POUCH, THE SURGEON REPORTED THAT WHILE ARTICULATING THE STAPLER, THE DEVICE BECAME DE-ARTICULATED AND SUDDENLY RECOILED IN THE OPPOSITE DIRECTION OF THE INTENDED ARTICULATION. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552538 ↗
• MalfunctionJun 1, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE INVOLVING CREATION OF A J-POUCH, THE SURGEON REPORTED THAT WHILE ARTICULATING THE STAPLER, THE DEVICE BECAME DE-ARTICULATED AND SUDDENLY RECOILED IN THE OPPOSITE DIRECTION OF THE INTENDED ARTICULATION. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349559 ↗
• MalfunctionMay 28, 2026Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAP GASTRIC SLEEVE PROCEDURE, IT WAS OBSERVED THAT THE STAPLE LINE ONLY WENT 2/3 OF THE WAY UP. GREEN 60 4000 RELOAD ON THE FIRST FIRE OF A SLEEVE. SURGEON SAID THERE WERE SEROSAL TEARS AND BLEEDING; AND SO HE HAD TO OVER SEW THE STAPLE LINE. THERE WAS A 8 MINUTE OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 25318020 ↗
• MalfunctionMay 18, 2026Positioning Failure; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE; IT WAS OBSERVED THAT IT WAS A LITTLE MORE DIFFICULT CLOSING THE DEVICE THAN NORMAL. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ARTICULATING TO THE LEFT ON THE STOMACH AND DURING THE FIRING SEQUENCE THE DEVICE MOVED TO THE HOME POSITION ON ITS OWN. THE FIRING SEQUENCE WAS COMPLETED WITH NO IRREGULARITIES IN THE STAPLE LINE REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209903 ↗
• MalfunctionMay 13, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A DUODENAL SWITCH PROCEDURE, THE SURGEON WAS UTILIZING THE ETHICON 4000 WITH SLR. THE LAST STAPLE LINE THE SURGEON MADE A COMMENT ABOUT SOME OF THE STAPLE LEGS STICKING OUT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161257 ↗
• MalfunctionMay 13, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE FIRING FROM THE DEVICE STOPPED MIDWAY THROUGH WHEN FIRING THROUGH TISSUE USING A 60 WHITE STAPLE LOAD. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159261 ↗
• MalfunctionMay 5, 2026Positioning Failure

  IT WAS REPORTED THAT DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON WAS FIRING A BLUE RELOAD ON THE STOMACH WITH THE STAPLER IN AN ARTICULATED POSITION. WHILE THE DEVICE WAS BEING FIRED, THE STAPLER UNEXPECTEDLY DE-ARTICULATED AT THE SAME TIME AND DID NOT FULLY RETURN TO THE HOME POSITION, INSTEAD STOPPING PARTWAY. THIS ISSUE OCCURRED TWICE DURING THE PROCEDURE. NO PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086148 ↗
• MalfunctionMay 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A ROBOTIC SLEEVE GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE ENTIRE INNER ROW (2D) ON THE REMNANT SIDE OF THE STOMACH DID NOT FORM. THE 2ND FIRE BLUE WITH SEAMGUARD WAS FINE, THEN IT HAPPENED AGAIN WITH THE 3RD FIRE BLUE (ER60B) & SEAMGUARD. THEY DECIDED TO OPEN A NEW STAPLER ADD THE LAST TWO FIRES WERE BLUE (ER60B) WITH SEAMGUARD AND THEY WERE PERFECT. NO DELAY OR PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082848 ↗
• MalfunctionMay 5, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS BARELY PULSING. THEN TOWARDS THE END IT WASN'T FIRING ANYMORE AND THEY HAD TO FORCE THE JAWS OPEN TO FINISH. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082365 ↗
• MalfunctionApr 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A DISTAL PANCREATOMY PROCEDURE, THE SURGEON FIRED THE STAPLER ACROSS THE PANCREATIC TISSUE. DURING AN INSPECTION OF THE STAPLE LINE, THE SURGEON WAS IMPRESSED BY THE QUALITY OF THE STAPLER ON THE REMAINING ORGAN. AFTER THE INSPECTION OF THE STAPLE LINE ON THE SPECIMEN BEING REMOVED, THE SURGEON NOTICED THAT THE DISTAL 1/3 OF THE STAPLES WERE MALFORMED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017832 ↗
• MalfunctionApr 27, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE, IT WAS OBSERVED THAT WHILE THE DEVICE WAS ARTICULATED AND CLAMPED ON THE TISSUE, THE JAWS MOVED BACK TO STRAIGHT POSITION DURING THE FIRING PROCESS. DEVICE HAD FIRED ONCE PRIOR WITHOUT INCIDENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH TWO MINUTES OF DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000979 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DISTAL PANCREAS PROCEDURE, THE SURGEON USED THE PRODUCT ON FRIDAY, ON (B)(6). BLEEDING WAS NOTED, AND THE SURGEON OVER SUTURED THE STAPLE LINE. ON (B)(6), THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM DUE TO BLEEDING. IT WAS REPORTED THAT THERE WAS SIGNIFICANT BLOOD LOSS HOWEVER, THE AMOUNT WAS UNKNOWN, AND THE PANCREAS WAS CRUSHED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 24980075 ↗
• MalfunctionMar 23, 2026Failure to Form Staple

  IT WAS REPORTED THAT, DURING A BYPASS REVISION PROCEDURE, THE SURGEON WAS HAVING ISSUES WITH THE ETHICON 4000 STAPLER. SHE FIRED A GREEN LOAD AND IT THE STAPLES DID NOT MAKE A B FORM. THE LEGS OF THE STAPLES WERE STICKING STRAIGHT UP. SHE THEN OPENED ANOTHER STAPLER AND TRIED ANOTHER GREEN LOAD AND THE SAME THING HAPPENED. SHE ALSO TRIED TO FIRE A BLACK LOAD AND THE STAPLES STILL DIDN¿T MAKE A B FORM. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663347 ↗
• MalfunctionMar 23, 2026Failure to Form Staple

  IT WAS REPORTED THAT, DURING A BYPASS REVISION PROCEDURE, THE SURGEON WAS HAVING ISSUES WITH THE ETHICON 4000 STAPLER. SHE FIRED A GREEN LOAD AND IT THE STAPLES DID NOT MAKE A B FORM. THE LEGS OF THE STAPLES WERE STICKING STRAIGHT UP. SHE THEN OPENED ANOTHER STAPLER AND TRIED ANOTHER GREEN LOAD AND THE SAME THING HAPPENED. SHE ALSO TRIED TO FIRE A BLACK LOAD AND THE STAPLES STILL DIDN¿T MAKE A B FORM. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663297 ↗
• MalfunctionMar 17, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A BYPASS REVISION PROCEDURE, THE SURGEON WAS HAVING ISSUES WITH THE ETHICON 4000 STAPLER. SHE FIRED A GREEN LOAD AND IT THE STAPLES DID NOT MAKE A B FORM. THE LEGS OF THE STAPLES WERE STICKING STRAIGHT UP. SHE THEN OPENED ANOTHER STAPLER AND TRIED ANOTHER GREEN LOAD AND THE SAME THING HAPPENED. SHE ALSO TRIED TO FIRE A BLACK LOAD AND THE STAPLES STILL DIDN¿T MAKE A B FORM. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619805 ↗
• MalfunctionMar 17, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A BYPASS REVISION PROCEDURE, THE SURGEON WAS HAVING ISSUES WITH THE ETHICON 4000 STAPLER. SHE FIRED A GREEN LOAD AND IT THE STAPLES DID NOT MAKE A B FORM. THE LEGS OF THE STAPLES WERE STICKING STRAIGHT UP. SHE THEN OPENED ANOTHER STAPLER AND TRIED ANOTHER GREEN LOAD AND THE SAME THING HAPPENED. SHE ALSO TRIED TO FIRE A BLACK LOAD AND THE STAPLES STILL DIDN¿T MAKE A B FORM. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619803 ↗
• MalfunctionMar 3, 2026Failure to Form Staple

  IT WAS REPORTED BY THE SURGEON TO THE SALES REP THAT SOME PHOTOS HE THOUGHT THE DISTAL PART OF THE STAPLE LINE DD NOT LOOK NORMAL, ALMOST AS IF IT OPENED UP A LITTLE. THE SURGEON SAID THE PROCEDURE WENT GREAT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496324 ↗
• MalfunctionFeb 19, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DUODENAL SWITCH PROCEDURE, THEY FIRED THE STAPLER HALFWAY AND THEY USED THE HOME BUTTON TO THEN OPEN THE JAWS AND REPLACE THE RELOAD. WITH THE NEW RELOAD THE STAPLER WOULD NOT FIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390827 ↗
• MalfunctionFeb 9, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THEY TRIED TO FIRE THE STAPLER WITH THE BLACK LOAD AND THE KNIFE WOULD NOT GO THROUGH. THE DEVICE WAS LOCKED OUT AND THEY PERFORMED A MANUAL OVERRIDE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296081 ↗