JustRight 5mm Stapler JR-ST25-2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00865163000102), received between Oct 12, 2016 and Jan 8, 2026 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A JUST RIGHT STAPLER PROCEDURE ON (B)(6) 2025, THE PHYSICIAN WAS PERFORMING A LAP GALLBLADDER REMOVAL, THE PHYSICIAN WAS WORKING ON THE CYSTIC DUCT AND MENTIONED THAT THE CLAMP COULD NOT BE USED DUE TO THE THICKNESS OF THE TISSUE. WHEN THE STAPLES WERE DEPLOYED IT WAS REPORTED THAT ONLY HALF WAY AND THERE WAS A CUT THAT WAS NOT STAPLED. THE PHYSICIAN HAD TO RESECT THE PART THAT MISFIRED. THE PROCEDURE WAS COMPLETED USING AN ENDO LOOP AND THE DEVICE WAS DISCARDED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure to Anastomose

  MAUDE report 24004102 ↗
• InjuryJun 23, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A BOWEL ANASTOMOSIS ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT A STAPLER WAS FIRED IN THIN AND PLIABLE TISSUE, AND WHEN THE STAPLE LINE INTEGRITY WAS CHECKED WITH SALINE FLOW, LEAKS WERE OBSERVED ON BOTH SIDES OF THE STAPLE LINE. THE PHYSICIAN CHANGED THE MODALITY AND USED AN ALTERNATIVE ANASTOMOSIS TO FINISH THE CASE. THE CASE WAS REPORTED AS FINISHED SUCCESSFULLY AND THE PATIENT WAS DOING FINE. THE DEICE WAS DISCARDED BY THE USER. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Failure to Anastomose

  MAUDE report 22308725 ↗
• MalfunctionJun 4, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A JUST RIGHT STAPLER PROCEDURE ON APRIL 7TH 2025, THE PHYSICIAN REPORTED THAT THE STAPLER HAD MISFIRED DURING A BLADDER FISTULA REPAIR ON A PEDIATRIC PATIENT. THE PHYSICIAN APPLIED ADEQUATE COMPRESSION BEFOREHAND FIRED ON THE FISTULA, AND WHEN THEY OPENED THE JAWS THERE WAS AN OPEN HOLE AND NO STAPLES HAD BEEN APPLIED TO THE TISSUE. THUS IT CUT BUT IT DID NOT FORM STAPLES. THE PHYSICIAN SWITCHED TO A DIFFERENT INSTRUMENT TO FINISH THE CASE. PHYSICIAN REPORTED THAT DUE TO THE ANGLE OF THE APPROACH SHE COULD NOT VISUALIZE THE TIP OF THE STAPLE TO CONFIRM PARALLEL JAWS BEFORE FIRING. SHE NOTED THAT IT WAS APPROPRIATELY THIN TISSUE. NO PATIENT INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure to Anastomose

  MAUDE report 22145696 ↗
• InjuryMay 21, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A JUST RIGHT STAPLER PROCEDURE ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT THE PHYSICIAN WAS NOT SATISFIED WITH THE STAPLE LINE THAT WAS DEPLOYED AND THAT HE USED ANOTHER MODALITY TO SEAL THE TISSUE. PHYSICIAN REPORTED THAT THE LINE FELL APART AFTER DEPLOYING. NO PATIENT INJURY WAS REPORTED AND NO MEDICAL INTERVENTION REPORTED. A IMAGE WAS PROVIDED IN WHICH IT WAS OBSERVED THAT THE TISSUE THAT WAS BEING STAPLED WAS THE BILE DUCT. PER INSTRUCTIONS FOR USE IT IS NOT RECOMMENDED TO USE THE STAPLER ON BILE DUCT AS THE USE IN THAT TISSUE CAN BE DESTRUCTIVE. THIS WAS AN OFF-LABEL USE.

  Patient problems: Failure to Anastomose

  MAUDE report 22061116 ↗
• InjuryJan 9, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON DECEMBER 12TH DURING A JUNIOR STAPLER PROCEDURE, THE STAPLE LINE RIPPED APART DURING A LOBECTOMY CAUSING CARDIAC ARREST OF THE PATIENT AND MASSIVE BLOOD LOSS. THE PATIENT WAS PEDIATRIC. PATIENT WAS RESUSCITATED AND TRANSPORTED TO THE ICU. DUE TO THE BLOOD LOSS ANESTHESIA HAD TO PROVIDE A LOT OF VOLUME TO ACCOUNT FOR THE BLOOD LOSS AND CARDIOTHORACIC TEAM REPAIRED THE VESSEL. 2 EVENTS WERE REPORTED 1 STAPLE GOT STUCK IN THE TROCAR AND THE BRONCHUS STAPLE LINE WAS WIDE OPEN. THE STAPLER WAS PLACED DOWN A 5 MM TROCAR AND STAPLED ACROSS THE BRONCHUS AND ASSOCIATED BRANCH OF THE PULMONARY ARTERY. WHEN THE STAPLER WAS BEING REMOVED IT GOT STUCK IN THE LAPAROSCOPIC TROCAR. THIS FORCED THE TEAM TO REMOVE THE ENTIRE TROCAR AND HAVE IT REPLACED. AFTER RE-ENTERING IT WAS OBSERVED BLEEDING AND BUBBLING, SO IT WAS DECIDED TO CONVERT TO A OPEN SURGERY. UPON OPENING IT WAS DISCOVERED THAT A BRANCH OF THE PULMONARY ARTERY WAS BLEEDING, WHICH PER THE PHYSICIAN SHOULD´VE BEEN SEALED BY THE STAPLE FIRE. THE PHYSICIAN GOT CONTROL OF THE BLEEDING AND ALLOWED ANESTHESIA TO RESUSCITATE THE PATIENT AT THIS POINT. AFTER RESUSCITATION IT WAS DISCOVERED THAT THE BRONCHUS WAS WIDE OP

  Patient problems: Bronchial Hemorrhage; Hemorrhage/Blood Loss/Bleeding; Organ Dehiscence

  MAUDE report 21113415 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 A 5-YEAR-OLD PATIENT RECEIVED AN APPENDECTOMY IN WHICH A JUST RIGHT STAPLER WAS USED. THE PROCEDURE WAS REPORTED AS SUCCESSFUL AND NO ISSUES DURING THE ORIGINAL PROCEDURE AND THE STAPLE LINE FORMED AND SEALED APPROPRIATELY. THE PHYSICIAN REPORTED THAT A WEEK LATER THE PATIENT DEVELOPED DENSE ADHESIONS AT THE STAPLE LINE WHICH REQUIRED INTERVENTION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s)

  MAUDE report 20306280 ↗
• InjuryAug 10, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 DURING A SURGERY THE JUST RIGH 5 MM STAPLER WAS BEING USED AS INDICATED , THE STAPLER MADE A SOUND THEN PUNCTURE A STRUCTURE WHICH CAUSED THE PATIENT TO BLEED. THE STAPLER WAS PLACED AROUND THE INFERIOR PULMONARY VEIN AND WHEN THE STAPLER WAS RELEASED IT BECAME CLEAR THAT THE STAPLES HAD NOT CLOSED AND THE STAPLER HAD CUT A HOLE IN THE INFERIOR PULMONARY VEIN WHICH CAUSED THE BLEEDING. DUE TO THIS EVENT THE EMERGENT GASPING AND A VENOTOMY WAS PERFORMED , THEN CLIPS WERE USED TO REINFORCE WITH A SILK TIE. THE VEIN WAS ONLY PARTIALLY TRANSECTED AND THERE WAS SOME DEBRIS FROM THE STAPLE IN THE BODY AFTER FIRING. THE PATIENT IS A 12 MONTHS OLD MALE 10 KG. THE PATIENT IS DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15205022 ↗
• InjuryJul 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2021, AFTER A THORACOSCOPIC RESECTION OF SEQUESTRATION, IT WAS NOTED UPON TRYING TO WAKE THE PATIENT UP THAT A FAIR AMOUNT OF BLOOD WAS ON THE CHEST TUBE DRESSING SITE AND IN THE PLEUR-EVAC. A THORACOSCOPIC SET UP WAS USED TO EVALUATE THE PATIENT AND NOTHING WAS FOUND SO THE PHYSICIAN CLOSED THE WOUND SITES, BUT IT WAS NOTICED SHORTLY AFTER THIS THAT BLOOD WAS COMING OUT OF THE CHEST TUBE, SO THE PHYSICIAN DECIDED TO PERFORM A THORACOTOMY AND OBSERVED THAT BLEEDING WAS COMING AROUND THE STAPLE LINE. THE PHYSICIAN THEN PROCEEDED TO CAUTERIZE THE SUTURE AND STOP THE BLEEDING. THE PATIENT WAS TRANSPORTED TO THE PICU. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure to Anastomose

  MAUDE report 15001867 ↗
• InjuryJul 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A GASTROSTOMY, THE JUSTRIGHT STAPLER MISFIRED WHILE TAKING DOWN THE EXISTING GASTROSTOMY. THIS INVOLVED CONVERTING TO OPEN GASTROSTOMY. THE TISSUE WAS FLATTENED FOR A WHILE BEFORE THE STAPLE WAS APPLIED TO IT AND IT WAS COMPLETELY CLOSED. THE PHYSICIAN HAD TO SEW THE HOLE CLOSED. NO ADDITIONAL INJURIES REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure to Anastomose

  MAUDE report 14938635 ↗
• InjuryFeb 2, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING STAPLER USE, THERE WAS A LARGE CRACK WHEN THE STAPLER WAS FIRED. FOLLOWING THIS, THE CUSTOMER WAS UNABLE TO RELEASE THE STAPLER FROM THE TISSUE. ADDITIONAL PORT WAS ADDED TO CUT OUT THE PORTION OF THE VESSEL WITH THE STAPLER ATTACHED. THE STAPLER WAS THEN REMOVED ALONG WITH THE CLAMPED TISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13430156 ↗
• MalfunctionJan 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY DURING THE STAPLER FIRING ON RENAL HILUM TISSUE, A LOUD CRUNCH NOISE WAS HEARD. UN-CRIMPED STAPLES WERE OBSERVED ALONG THE STAPLE LINE. THE PATIENT WAS LESS THAN 18 YEARS OF AGE, BUT NO FURTHER PATIENT INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13237268 ↗
• MalfunctionDec 20, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE SURGEON IDENTIFIED MALFORMED STAPLES ON THE RIGHT SIDE OF THE CUT LINE NEAR THE DISTAL TIP OF THE STAPLE LINE. PATIENT INFORMATION WAS NOT PROVIDED. PATIENT IMPACT WAS ADDITIONAL SURGICAL INTERVENTION. THE PATIENT HAS NOW RECOVERED AND HAS BEEN DISCHARGED. THE DISPOSABLE STAPLER HANDLE WAS DISPOSED OF AN WAS NOT AVAILABLE FOR RETURN, BUT THE RELOAD USED DURING THE EVENT WAS RETURNED FOR INVESTIGATION.

  Patient problems: Bronchial Hemorrhage

  MAUDE report 13044205 ↗
• MalfunctionOct 19, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED DURING THE PROCEDURE THE SURGEON STAPLED THE BRONCHUS BUT SAID THE STAPLES DID NOT FORM INTO B'S. THE SURGEON SEWED OVER THE STAPLE LINE TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661091 ↗
• InjuryMar 25, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A THORACOSCOPY PROCEDURE, THE HANDLE OF THE STAPLER BROKE APART WHILE THE SURGEON WAS COMPRESSING TISSUE, TO STAPLE THE LUNG. THE ANVIL WAS STUCK IN A CLOSED POSITION AND THE SURGEON HAD TO MANUALLY PRY OPEN THE JAWS. THE PROCEDURE WAS COMPLETED USING CLIPS TO STOP THE BLEEDING. THERE WERE NO REPORTED ADDITIONAL PATIENT IMPACTS.

  Patient problems: Perforation

  MAUDE report 11569112 ↗
• MalfunctionFeb 25, 2019Failure to Fire

  A DISPOSABLE LAPAROSCOPIC STAPLER WAS OPENED FOR PATIENT'S THORASCOPIC LUNG SURGERY. THE STAPLER LOAD THAT CAME WITH THE STAPLER FAILED TO FIRE ANY STAPLES. NO HARM CAME FROM THE ATTEMPT OF USE. ANOTHER STAPLER LOAD WAS OPENED AND USED WITH THE ORIGINALLY OPENED STAPLER HANDPIECE WITHOUT ISSUE. MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, JUST RIGHT 5 MM STAPLER (PER SITE REPORTER).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8365853 ↗
• InjuryOct 12, 2016Use of Device Problem; Failure to Form Staple

  ON (B)(6) , THE SURGEON WAS PERFORMING A LEFT LOWER LOBECTOMY ON A (B)(6) MO OLD PATIENT. THE CASE HAD STARTED LAPAROSCOPICALLY BUT HAD CONVERTED TO OPEN PRIOR TO USE OF THE JUSTRIGHT DEVICE(S), SO THERE WAS NO VIDEO OF THE EVENT. HE APPLIED THE JAWS TO THE HYLUM OF THE PULMONARY VEIN, WHICH WAS APPROXIMATELY 1CM WIDE. HE COULD NOT RECALL HOW HE CLOSED THE JAWS. HE COULD NOT VERIFY THAT HE CLAMPED THE WHITE CLAMP LEVER PRIOR TO FIRING THE STAPLES. HE STARTED TO FIRE BY REACHING FOR THE BLUE FIRE TRIGGER LEVER AND "COULD FEEL SOMETHING WASN'T RIGHT." THE SENIOR SCRUB GUIDED HIM TO STOP IN THE MIDDLE OF FIRING AS SHE PERCEIVED HE WAS USING IT INCORRECTLY. HE REMOVED THE STAPLER FROM THE TISSUE, STATING THAT HE DIDN'T THINK IT LAYED DOWN ANY STAPLES AND THAT IT WAS HARD TO GET THE DEVICE OFF OF THE TISSUE. HE CLAMPED THE VEIN WITH A HEMOSTAT. WE CANNOT CONFIRM IF THERE WAS ANY BLEEDING AT THIS TIME. HE AND THE STAFF REVIEWED THE STAPLER SETUP SHEET WITH OPERATING INSTRUCTIONS THAT HAD PREVIOUSLY BEEN PROVIDED BY JUSTRIGHT. HE OPENED A NEW DEVICE. WHEN HE FIRED THE SECOND DEVICE, SOME STAPLES CRIMPED, SOME WERE STILL STRAIGHT. THE VEIN HEMORRHAGED ONCE THE HEMOSTAT WAS REMOVED. CLIPS W

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6023719 ↗