ECHELON ECH60LRecalls & reported problems

Summary

The FDA's MAUDE database contains 467 adverse event reports that list this exact device (DI 10705036034988), received between Dec 15, 2022 and Sep 14, 2026 — classified as 28 injuries, 439 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (157 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 467 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Difficult to Remove

  During a lap-appy "[laparoscopic appendectomy]", stapled appy. went to remove stapler from articulated position and patient could not. hat to remove port and then stapler.

  Patient problems: Insufficient Information

  MAUDE report 50753660 ↗
• MalfunctionSep 14, 2026Difficult to Open or Close

  stapler fired with inability to immediately open manually. It appears the stapler did have a portion of a robotic instrument tip within the jaw. The resident clamped the tissue prior to firing the stapler and did not feel the obstruction. We were able to get ahold of the rep and eventually open jaw.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753150 ↗
• MalfunctionAug 31, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520366 ↗
• MalfunctionAug 31, 2026Difficult to Open or Close; Mechanical Jam; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520068 ↗
• MalfunctionAug 24, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410491 ↗
• MalfunctionAug 20, 2026Positioning Failure; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50350015 ↗
• MalfunctionJul 27, 2026Difficult to Open or Close

  It was reported that during an unspecified surgical procedure, it was observed that the device did not open. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045981 ↗
• MalfunctionJul 27, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045906 ↗
• MalfunctionJul 27, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50045895 ↗
• InjuryJul 27, 2026Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  It was reported that during a Laparoscopic Proximal Gastrectomy, the first blue reload was used on stomach junction with esophageal - no Bleed. The second gold reload was used on stomach lesser curvature towards greater curvature where surgeon performed pre-compression for 30 seconds and pulse firing techniques - no bleed on staple line. Third gold reload gold on after the second reload towards greater curvature where surgeon performed pre-compression 30 second and pulse firing techniques - bleed on staple line. Surgeon performed suturing on staple line. Fourth Firing with gold reload after the third reload towards greater curvature where surgeon performed pre-compression for 30 seconds and pulse firing techniques - bleed on staple line. Surgeon performed suturing on staple line. Fifth firing with blue reload on small intestine where surgeon performed pre-compression for 30 seconds and and pulse firing techniques - bleed on staple line. Surgeon performed suturing on staple line. Sixth firing with white reload on esophagus and intestine anastomosis. Surgeon performed pre-compression for 30 seconds and pulse firing techniques - no bleed on staple line. Seventh firing with blue reload

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50011585 ↗
• MalfunctionJun 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612979 ↗
• MalfunctionJun 23, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THEY WERE USING AN ETHICON ECHELON STAPLER, THE STAPLER MISFIRED. THERE WERE 3 ROWS OF STAPLES ON THE STAPLER. THE FIRST 2 ROWS WERE GOOD. IT LOOKS LIKE STAPLE LINE 3 HAD ONE SINGLE OPEN STAPLE. THE STAPLE LINE ON SPECIMEN TORE PER THE REP AND THEM. THE SPECIMEN WAS LOOKED AT BY THE SURGEON AND THE VENDOR REPS. THE STAPLER WAS TAKEN OFF THE FIELD, BOXED WITH A PATIENT STICKER AND TAKEN TO THE MAIN OR FRONT DESK. THE CASE PROCEEDED WITHOUT FURTHER COMPLICATIONS. UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595312 ↗
• MalfunctionJun 15, 2026Failure to Fire; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A THORACIC PROCEDURE, THE DOCTOR WAS USING THE ECH60L WITH A BLACK RELOAD AND SLR TO TRANSECT LUNG TISSUE. THE STAPLER CLOSED ON THE TISSUE AND BEGAN TO FIRE BUT THEN LOCKED OUT AND WOULD NOT CONTINUE TO FIRE HOME BUTTON WAS USED TO RETRACT THE KNIFE BLADE. SURGEON REQUESTED A NEW STAPLER WHICH WORKED AS DESIRED. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25510129 ↗
• MalfunctionJun 8, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN STAPLING STARTED, THE CLAMP STOPPED IMMEDIATELY, AS IF THE BATTERY WAS DEFECTIVE.WHEN THE CLAMP WAS OPENED ON THE SECTION, STAPLING HAD NOT BEEN PERFORMED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428047 ↗
• MalfunctionJun 3, 2026Ejection Problem

  IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, THE STAPLER RELOAD WAS SUCCESSFULLY REMOVED. WHEN STAFF ATTEMPTED TO LOAD A NEW RELOAD, THE RELOAD COULD NOT BE ADVANCED OR SLID INTO THE STAPLER PROPERLY, PREVENTING SUCCESSFUL RELOADING OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375991 ↗
• MalfunctionMay 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE; IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321726 ↗
• MalfunctionMay 13, 2026Delivered as Unsterile Product

  DURING A SURGICAL PROCEDURE FOR BPH (BENIGN PROSTATIC HYPERPLASIA), WHEN OPENING THE ECHELON 3000/340 STAPLER WITH A 60MM JAW, IT WAS IDENTIFIED THAT, DESPITE THE OUTER PACKAGING BEING INTACT AND PROPERLY SEALED, THE PLASTIC SLEEVE COVERING THE JAW DISPLAYED DROPLETS OF MOISTURE, RESEMBLING CONDENSATION/VAPOR. THE FINDING WAS OBSERVED AT THE MOMENT THE STERILE PRODUCT WAS REMOVED FROM THE TRANSPARENT PACKAGING AND HANDED TO THE SCRUB NURSE. THE CONDITION WAS SEEN BY THE NURSING TEAM AND BY THE OPERATING SURGEON. GIVEN THE INABILITY TO GUARANTEE THE STERILITY OF THE PRODUCT, THE MATERIAL WAS INITIALLY SEGREGATED AND A REPLACEMENT WAS REQUESTED FROM THE PHARMACY. AT THE PHARMACY, ALL AVAILABLE UNITS OF THE ECHELON 3000/340 WITH A 60MM JAW BELONGED TO THE SAME LOT. UPON OPENING THE PRIMARY PACKAGING FOR INSPECTION, IT WAS NOTED THAT ALL UNITS SHOWED THE SAME MOISTURE-DROPLET APPEARANCE IN THE JAW AREA, TOTALING 6 UNITS THAT ARE SEGREGATED IN THE SURGICAL CENTER PHARMACY AND 1 UNIT THAT WAS OPENED AND DISCARDED. AS A MITIGATION ATTEMPT, AN ECHELON 340/440 WITH A 60MM JAW WAS REQUESTED AND, UPON OPENING THAT UNIT, A DROPLET WAS ALSO OBSERVED, THOUGH IN A MINIMAL, ALMOST IMPERCEPTIBLE AM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161609 ↗
• MalfunctionMay 12, 2026Failure to Fire; Difficult to Open or Close; Activation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BYPASS PROCEDURE, IT WAS OBSERVED THAT THE STAPLER STOPPED MIDWAY AND BECAME BLOCKED AT THE FIRST STAPLING. THE SURGEON PERFORMED AN EMERGENCY MANEUVER TO OPEN THE STAPLER BUT IT REMAINED JAMMED AND CLOSED. AFTER SEVERAL ATTEMPTS THE STAPLER OPENED AND UNLOCKED. THERE WERE NO PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149920 ↗
• MalfunctionMay 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON ATTEMPTED TO STAPLE THE STOMACH TO CREATE A SLEEVE BUT THE STAPLER DID NOT STAPLE. ADDITIONAL MAGAZINES WERE TESTED ON COMPRESSES AND NO STAPLES WERE DEPLOYED. A NEW STAPLER WAS TRIED AND FUNCTIONED CORRECTLY. NO PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085622 ↗
• MalfunctionMay 5, 2026Difficult to Open or Close; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT AFTER THE STAPLER WAS FIRED THE SECOND TIME, IT WOULD NOT OPEN TO LOAD THE CARTRIDGE AGAIN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083152 ↗
• MalfunctionApr 30, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BATTERY DID NOT WORK AS IT SHOULD, AS IT WAS VERY SLOW. THEY TRIED TO TAKE THE BATTERY OUT AND PUT IT IN AGAIN BUT WITH THE SAME RESULT, CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050128 ↗
• MalfunctionApr 30, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLER COULD NOT BE FIRED AT THE FIFTH FIRING AFTER FOUR SUCCESSFUL FIRINGS. WERE MALFORMED AFTER FIRING. THEY TOOK THE STAPLER OUT OF THE PATIENT, REMOVED AND REINSERTED THE BATTERY; AND THE STAPLER WAS ABLE TO FIRE WITHOUT ISSUES SUBSEQUENTLY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049642 ↗
• MalfunctionApr 29, 2026Failure to Fire; Ejection Problem

  IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE NEVER FIRED SPECIFICALLY ON THE FIFTH FIRING. FOR SPECIFICATION, THERE WAS NO PROBLEM AT ALL WITH THE FIRST FOUR FIRINGS. WHEN THE TECH WAS TRYING TO LOAD THE FIFTH RELOAD, THERE'S A STAPLER RELOAD INTO THE JAWS OF THE STAPLER, IT WOULD NOT FIT. THE TECH TRIED SEVERAL DIFFERENT MANEUVER TO TRY TO FIT THE RELOAD IN AND IT WOULD NOT FIT. THEY OPENED A BRAND NEW RELOAD AND ATTEMPTED TO TRY TO PUT IN THE NEW STAPLER RELOAD INTO THE JAWS OF THE STAPLER. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033680 ↗
• MalfunctionApr 29, 2026Failure to Cut; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLER BECAME STUCK AT THE END OF THE SECTION. AN ALTERNATIVE METHOD WAS USED TO OPEN THE STAPLER AND RELEASE THE TISSUE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032148 ↗
• MalfunctionApr 28, 2026Failure to Fire

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS NOT WORKING WHEN THEY TRIED TO DRY FIRE PRIOR TO DOING THE CASE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021722 ↗