GIA GIA8038LRecalls & reported problems

Summary

The FDA's MAUDE database contains 580 adverse event reports that list this exact device (DI 10884523007251), received between Mar 22, 2017 and Sep 30, 2026 — classified as 5 deaths, 140 injuries, 435 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (193 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825, K221013); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 580 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952459 ↗
• MalfunctionSep 22, 2026Failure to Fire; Component or Accessory Incompatibility

  Patient problems: Insufficient Information

  MAUDE report 50860175 ↗
• MalfunctionAug 13, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232991 ↗
• MalfunctionJun 26, 2026Failure to Fire; Fail-Safe Problem

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANT, THE WHITE FLAG INTERLOCK (KNIFE BLADE COVER) WAS ALREADY ENGAGED, AND THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED, AS A RESULT, THE INSTRUMENT DID NOT FIRE. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25635071 ↗
• MalfunctionJun 25, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN ONCOLOGICAL LYMPH NODE REMOVAL, DURING THE SMALL BOWEL AND MESENTERY RESECTION, IT WAS NOTED THAT THE STAPLE LINE WAS INCOMPLETE. TO RESOLVE THE ISSUE, AN ADDITIONAL SMALL BOWEL WAS RESECTED AND RE-STAPLING WAS DONE. THE SURGICAL TIME WAS EXTENDED FOR 5 TO 10 MINUTES AS A RESULT.

  Patient problems: Tissue Breakdown

  MAUDE report 25622642 ↗
• MalfunctionMay 22, 2026Misfire

  IT WAS REPORTED THAT DURING A BOWEL RESECTION, THE STAPLER LOADING UNIT DID NOT FIRE COMPLETELY TO THE DISTAL END. THE CARTRIDGE WAS REMOVED AND REPLACED WITH ANOTHER CARTRIDGE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25262859 ↗
• MalfunctionApr 22, 2026Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN RIGHT HEMICOLECTOMY, THE LOADING UNIT WAS USED FOR COLON TRANSECTION WHEN THE BLACK HANDLE PARTIALLY FIRED WITH THE DISTAL END FAILING TO CUT AND THE RELOAD FAILING TO FORM STAPLES. A NEW OPEN STAPLER WAS OPENED TO COMPLETE THE CASE. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24949957 ↗
• MalfunctionApr 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE LOADING UNIT WAS REPLACED 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 24931522 ↗
• MalfunctionApr 16, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, AFTER LOADING THE RELOAD, THE DEVICE COULD NOT BE PUSHED, AND THE DEVICE FAILED TO FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894351 ↗
• MalfunctionApr 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING USE OF THE OPEN STAPLER, POOR STAPLE FORMATION OCCURRED DISTALLY. THE STAPLE LINE REQUIRED OVERSEWING TO FIX THE STAPLE LINE.

  Patient problems: Tissue Breakdown

  MAUDE report 24876793 ↗
• MalfunctionMar 31, 2026Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE PARTIALLY FIRED. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747747 ↗
• MalfunctionMar 18, 2026Sharp Edges

  IT WAS REPORTED THAT INTRAOPERATIVELY, WHEN LOADING THE NEXT CARTRIDGE, THE STAPLES ACTUALLY CAME UP AND PUNCTURED THE NURSE'S SKIN. THEN AFTER SUCCESSFULLY FIRING TWO RELOADS, SOME STAPLES WERE PROTRUDING FROM THE CARTRIDGE AND PRICKED THE NURSE'S HAND. NO INTERVENTION WAS DONE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24626458 ↗
• MalfunctionMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOPERATIVELY, WHEN LOADING THE NEXT CARTRIDGE, THE STAPLES ACTUALLY CAME UP AND PUNCTURED THE NURSE'S SKIN. THEN AFTER SUCCESSFULLY FIRING TWO RELOADS, SOME STAPLES WERE PROTRUDING FROM THE CARTRIDGE AND PRICKED THE NURSE'S HAND. NO INTERVENTION WAS DONE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24626257 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A SMALL BOWEL TO SMALL BOWEL ANASTOMOSIS USING AN 80MM LINEAR CUTTING STAPLER AND THREE 80MM BLUE RELOADS ON (B)(6) 2025. A SECOND SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2025 DUE TO POST-OPERATIVE COMPLICATIONS INDICATING ANASTOMOTIC FAILURE AND LEAKAGE OF GASTRIC CONTENT, DURING WHICH A LEAKAGE AT THE ANASTOMOSIS SITE WAS CONFIRMED. THE STAPLE LINES WERE REINFORCED WITH SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24064848 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A SMALL BOWEL TO SMALL BOWEL ANASTOMOSIS USING AN 80MM LINEAR CUTTING STAPLER AND THREE 80MM BLUE RELOADS ON (B)(6) 2025. A SECOND SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2025 DUE TO POST-OPERATIVE COMPLICATIONS INDICATING ANASTOMOTIC FAILURE AND LEAKAGE OF GASTRIC CONTENT, DURING WHICH A LEAKAGE AT THE ANASTOMOSIS SITE WAS CONFIRMED. THE STAPLE LINES WERE REINFORCED WITH SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24064846 ↗
• MalfunctionJan 9, 2026Misfire; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN RIGHT HEMICOLECTOMY PROCEDURE, AFTER DETACHING THE COLORECTUM, THE SURGEON OBSERVED THAT THE DEVICE FIRED PARTIALLY AND THE STAPLE FORMATION WAS POOR. THE STAPLE LINE WAS FIXED BY OVERSEWING, AND A NEW RELOAD WAS USED TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 24027783 ↗
• MalfunctionJan 2, 2026Misfire

  IT WAS REPORTED THAT DURING AN OPEN PARTIAL HEPATECTOMY, THE HANDLE AND RELOAD PARTIALLY FIRED AND COULD NOT CONTINUE OPERATION AFTER THE BLACK HANDLE WAS PUSHED HALFWAY. THE SURGEON ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE DEVICE WITH A NEW RELOAD, BUT THE DEVICE STILL COULD NOT CONTINUE. THE SURGEON THEN REPLACED IT WITH A NEW HANDLE AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952492 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY OF A LAPAROSCOPY DIAGNOSTIC CONVERTED TO OPEN LAPAROTOMY FOR RELEASE OF SMALL BOWEL OBSTRUCTION ON (B)(6) 2025, AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS GIVEN PREOPERATIVE INTRAVENOUS (IV) FLUIDS AND IV ANTIBIOTICS. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM TABLE AND PLACED IN SUPINE POSITION. A TIME OUT WAS COMPLETED. THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE SURGEON REOPENED THE LEFT MID QUADRANT 5 MM INCISION AND INSERTED A 5 MM CAMERA COMPLEX UNDER DIRECT VISION TO THE ABDOMEN, NO TROCAR INJURY APPRECIATED. THE DOCTOR THEN PLACED A RIGHT LOWER RIGHT UPPER QUADRANT SECONDARY 5 MM TROCAR; NO TROCAR INJURY WAS APPRECIATED. UPON ENTERING THE ABDOMEN THERE WAS NO PURULENT OR FECULENT CONTAMINATION THERE WAS NO FLUID IN THE ABDOMEN THERE WAS DILATED PROXIMAL SMALL BOWEL AND DISTAL DECOMPRESSED SMALL BOWEL WAS ABLE TO LOCATE THE TERMINAL ILEUM AND FOLLOW THE DECOMPRESSED BOWEL BACK TO THE ROOT OF THE SMALL BOWEL MESENTERY HOWEVER THE SURGEON WAS UNABLE TO KEEP THE DILATED SMALL BOWEL OUT OF THE WAY THEREFORE OPENED THE PREVIOUS MIDLINE LAPAROTOMY INCISION THE DOCTOR WAS ABLE TO FOLLOW THE DECOMPRESS

  Patient problems: Obstruction/Occlusion

  MAUDE report 23890810 ↗
• MalfunctionDec 22, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY , THE DEVICE DID NOT FIRE COMPLETELY TO THE DISTAL END. THE DEVICE WAS REPLACED AND ANOTHER NEW RELOAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873484 ↗
• MalfunctionDec 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE DEVICE DID NOT FIRE DURING SET-UP PRIOR TO USE. THE ISSUE WAS RESOLVED BY REPLACING THE WITH A NEW ADDITIONAL RELOAD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843271 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON POST OPERATIVE LAPAROSCOPIC LEFT HEMICOLECTOMY CONVERTED TO OPEN WHICH OCCURRED ON (B)(6) 2025, THE STAPLE LINE LEAKED THE CONTENTS BEING HELD BY THE TISSUE. THE LEAK WAS DISCOVERED FEW DAYS LATER POST-OPERATIVELY. THE PROCEDURE INVOLVED A COLONIC RESECTION WITH SIDE-TO-SIDE COLO-COLONIC ANASTOMOSIS AND SMALL BOWEL MASS RESECTION. INITIALLY, A POINT OF TRANSECTION WAS SELECTED JUST DISTAL TO THE LEFT MIDDLE COLIC ARTERY, AND A GIA 80 MM LOADING UNIT WAS USED TO DIVIDE THE COLON. A SIDE-TO-SIDE ISOPERISTALTIC COLO-COLONIC ANASTOMOSIS WAS THEN CREATED USING A GIA 75 MM STAPLER, WITH THE STAPLE LINE AND SUTURE LINES OVERSEWN USING 3-0 SILK IN A LEMBERT STITCH TO REINFORCE THE ANASTOMOSIS. THE SMALL BOWEL MASS, LOCATED IN THE SEROSA, WAS RESECTED BY TRANSECTING THE BOWEL BOTH PROXIMALLY AND DISTALLY TO THE MASS WITH THE GIA 75 MM STAPLER. ANOTHER SIDE-TO-SIDE ISOPERISTALTIC ANASTOMOSIS WAS CREATED, AND THE ENTEROTOMY WAS CLOSED WITH 4-0 PDS SUTURES, WITH THE SUTURE AND STAPLE LINES OVERSEWN WITH 3-0 SILK SUTURES. THE FASCIA WAS CLOSED WITH RUNNING 1 PDS SUTURES, AND THE SKIN WAS CLOSED WITH STAPLES. THE PATIENT EXPERIENCED A LIFE-THREATENING EVEN T DUE TO THE ST

  Patient problems: Failure to Anastomose

  MAUDE report 23800598 ↗
• MalfunctionDec 12, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A HEPATECTOMY PROCEDURE, THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED. THE INSTRUMENT DID NOT FIRE. THE DEVICE WAS REPLACED WITH ANOTHER CARTRIDGE OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796686 ↗
• MalfunctionDec 2, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING AN ESOPHAGEAL SURGERY, ALTHOUGH FIRING WAS POSSIBLE DURING THE CREATION OF THE GASTRIC TUBE, AFTER REPLACING THE CARTRIDGE DURING CERVICAL ANASTOMOSIS, FIRING COULD NOT BE DONE (AROUND THE THIRD OR FOURTH SHOT). FURTHERMORE, WHEN ANOTHER CARTRIDGE WAS USED, THE FIRING COULD NOT BE DONE, SO THE ENTIRE STAPLER WAS REPLACED WITH A NEW ONE WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692383 ↗
• MalfunctionDec 2, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING AN ESOPHAGEAL SURGERY, ALTHOUGH FIRING WAS POSSIBLE DURING THE CREATION OF THE GASTRIC TUBE, AFTER REPLACING THE CARTRIDGE DURING CERVICAL ANASTOMOSIS, FIRING COULD NOT BE DONE (AROUND THE THIRD OR FOURTH SHOT). FURTHERMORE, WHEN ANOTHER CARTRIDGE WAS USED, THE FIRING COULD NOT BE DONE, SO THE ENTIRE STAPLER WAS REPLACED WITH A NEW ONE WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692266 ↗
• MalfunctionNov 24, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A BOWEL PROCEDURE, THE STAPLER WITH A BLUE CARTRIDGE WAS PREPARED, CLEANED, AND ASSEMBLED FOLLOWING THE CORRECT STEPS, BUT DID NOT STAPLE. A THIRD CARTRIDGE WAS LOADED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628914 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825, K221013. One submission often covers many models, so check the product and lot details in each record.

• Z-0747-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or tra
• Z-0748-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection
• Z-0005-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric
• Z-0008-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0009-2021 · Aug 12, 2020 · Open, Classified
  Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applicat
• Z-0007-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic
• Z-0006-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0002-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0001-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gyn
• Z-0003-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0004-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-1264-2020 · Jan 17, 2020 · Terminated
  Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT

…and 58 more.