Endo Universal 65 173052Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10884521070523), received between Aug 23, 2017 and Sep 29, 2026 — classified as 6 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (67 reports).

4 other recalls cover devices cleared under the same FDA submission (K912097); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Misfire

  According to the reporter during a gastric bypass procedure, the powered Handle experienced a firing issue. The device was replaced to resolve the issue. No patient injury were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936682 ↗
• MalfunctionSep 21, 2026Misfire

  Patient problems: Insufficient Information

  MAUDE report 50848832 ↗
• MalfunctionSep 21, 2026Misfire; Failure to Fire; Firing Problem

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845085 ↗
• MalfunctionSep 21, 2026Misfire; Failure to Fire

  It was reported that during a gastric bypass, the device stops firing. Another same device with different lot number was used to resolve the issue.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840058 ↗
• MalfunctionSep 21, 2026Material Split, Cut or Torn; Firing Problem

  According to the reporter, intra-operatively, the stapler fired but became increasingly difficult to fire. The firing action grew heavier. The handle became harder and harder to squeeze. Additionally, the plastic was coming loose from the tip. Another device from another lot number was used to complete the case. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836276 ↗
• MalfunctionSep 17, 2026Failure to Fire; Insufficient Device Problem Information; Firing Problem

  According to the reporter, during a gastric bypass procedure, at the start of the procedure, the firing was not smooth then stopped. The device was replaced with the same model from a different lot number to complete the procedure. No patient injury was reported.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802560 ↗
• MalfunctionSep 16, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794730 ↗
• MalfunctionJun 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, STAPLING WAS NOT POSSIBLE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566627 ↗
• MalfunctionApr 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE BILATERAL INGUINAL HERNIA REPAIR, THE STAPLES DID NOT CLOSE AND THEREFORE DID NOT HOLD. FALLEN STAPLES FROM THE PATIENT CAVITY WERE RECOVERED ONE BY ONE WITH PLIERS, AND THE DURATION OF THE OPERATION WAS EXTENDED BY APPROXIMATELY 15 MINUTES. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018742 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REVIEW OF SECONDARY DATA SOURCES OF A STUDY ABOUT THE COMPLICATION OF INTERNAL HERNIATION ON INDEX IN 681 PATIENTS, WHICH ALL CAUSED READMISSIONS IN 118 PATIENTS AND ABDOMINAL HERNIA READMISSIONS IN TWO PATIENTS.

  Patient problems: Hernia

  MAUDE report 24956681 ↗
• MalfunctionMar 19, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE HERNIA STAPLER, THE STAPLES DID NOT CLOSE AND REMAINED OPEN WHICH LED TO EXTENDED SURGICAL TIME OF AROUND 30 MINUTES. THE DEVICE WAS REPLACED WITH ANOTHER STAPLER, AND THE AFFECTED AREA WAS RESECTED AND RE-STAPLED.

  Patient problems: Tissue Breakdown

  MAUDE report 24636484 ↗
• MalfunctionFeb 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS, AT THE LAST STEP WHEN CLOSING THE MESENTERY, SUDDENLY A PLASTIC PIECE WAS BROKE OFF AT THE TIP, OUTSIDE THE PATIENT, WHEN THE USER LOADED THE INSTRUMENT WITH MORE CLIPS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401421 ↗
• MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC BYPASS, DURING THE LAST STEP WHEN CLOSING THE MESENTERY, THE HANDLE BROKE WHEN THE SURGEON TRIED TO PLACE THE STAPLER. A SMALL PLASTIC PIECE IN THE HANDLE FELL OFF OUTSIDE THE PATIENT. ANOTHER DEVICE FROM ANOTHER LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891410 ↗
• MalfunctionOct 21, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL (TAPP) HERNIA PROCEDURE, THE STAPLES ON THE FIRST STAPLER DID NOT COME OUT, AND THE CARTRIDGE COULD NOT BE CHANGED ON THE SECOND STAPLER. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346660 ↗
• MalfunctionSep 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BARIATRIC BYPASS SURGERY, A SMALL PLASTIC TIP FROM THE LOADING UNIT OF THE FIRST DEVICE WAS FOUND TO BE MISSING AT THE END OF THE PROCEDURE WHEN THE DEVICE WAS BEING USED TO CLOSE INCISIONS. THE MISSING TIP WAS LOCATED IN THE CAVITY AND REMOVED. A SECOND DEVICE, WHICH APPEARED SLIGHTLY MISALIGNED, WAS UNPACKED AND USED WITHOUT PROBLEMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033599 ↗
• MalfunctionJul 3, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR, THE HANDLE OF THE DEVICE WAS LOCKED AND UNABLE TO ACTIVATE WHEN CHECKED BY THE NURSE AT THE BEGINNING OF THE SURGERY AND PRIOR TO THE PATIENT'S USE. TO RESOLVE THE ISSUE, ANOTHER DEVICE OF THE SAME TYPE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398800 ↗
• MalfunctionJul 3, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER REPLACING THE CARTRIDGE, THE 2 DEVICES COULD NOT BE FIRED. ANOTHER HANDLE WAS USED, AND THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391882 ↗
• MalfunctionJul 3, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER REPLACING THE CARTRIDGE, THE 2 DEVICES COULD NOT BE FIRED. ANOTHER HANDLE WAS USED, AND THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391860 ↗
• MalfunctionMay 28, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, WHEN THE SURGEON TRIED TO FIRE THE STAPLER, IT DID NOT FIRE ANY STAPLES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098195 ↗
• MalfunctionMay 21, 2025Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ONLY TWO STAPLES WERE SUCCESSFULLY DEPLOYED, AND SUBSEQUENT ATTEMPTS TO PUSH OUT ADDITIONAL STAPLES WERE UNSUCCESSFUL. THE SMALL HANDLE OF THE DEVICE BROKE WHEN THE SURGEON ATTEMPTED TO PUSH FURTHER. THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063366 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE RELOAD WAS BEING CHANGED, THE PLASTIC COMPONENT OF THE RELOAD SNAPPED AND BROKE. THE BROKEN PART DID NOT DISENGAGE FROM THE DEVICE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW TACKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022740 ↗
• MalfunctionApr 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE, THE DEVICE WAS ABLE TO FIRE 2¿3 STAPLES AT THE BEGINNING. HOWEVER, AFTERWARD, THE HANDLE BECAME ¿BLOCKED¿ UNABLE TO OPEN OR CLOSE AND THEREFORE COULD NOT FIRE ANY MORE STAPLES. THE SAME ISSUE OCCURRED WITH ANOTHER STAPLER. THE ISSUE WAS RESOLVED BY USING A NEW ENDO UNIVERSAL STAPLER, WHICH FUNCTIONED CORRECTLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876964 ↗
• MalfunctionApr 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE, THE DEVICE WAS ABLE TO FIRE 2¿3 STAPLES AT THE BEGINNING. HOWEVER, AFTERWARD, THE HANDLE BECAME ¿BLOCKED¿ UNABLE TO OPEN OR CLOSE AND THEREFORE COULD NOT FIRE ANY MORE STAPLES. THE SAME ISSUE OCCURRED WITH ANOTHER STAPLER. THE ISSUE WAS RESOLVED BY USING A NEW ENDO UNIVERSAL STAPLER, WHICH FUNCTIONED CORRECTLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876956 ↗
• MalfunctionMar 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS, WHILE ON THE LAST STEP OF THE PROCEDURE AND WHEN CLOSING THE MESENTERY, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A NEW DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21714435 ↗
• MalfunctionMar 13, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC BYPASS, THE STAPLER BLOCKED AFTER FIRING TWICE. THE STAPLER WAS RELOADED BUT THE DEVICE STILL DID NOT WORK. THE DEVICE NO LONGER FIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599733 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K912097. One submission often covers many models, so check the product and lot details in each record.

• Z-2255-2020 · May 12, 2020 · Open, Classified
  Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of
• Z-2254-2020 · May 12, 2020 · Open, Classified
  Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of
• Z-2252-2020 · May 12, 2020 · Open, Classified
  Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair
• Z-2253-2020 · May 12, 2020 · Open, Classified
  Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair