GIA GIA6038LRecalls & reported problems

Summary

The FDA's MAUDE database contains 199 adverse event reports that list this exact device (DI 10884523007220), received between May 22, 2017 and Sep 29, 2026 — classified as 3 deaths, 49 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (68 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 199 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Form Staple

  It was reported that after firing, the device had staple warping. The device was replaced.

  Patient problems: Tissue Breakdown

  MAUDE report 50934880 ↗
• MalfunctionMay 1, 2026Component or Accessory Incompatibility; Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CIRCULAR STAPLER FIRED BUT IT DID FORM PROPERLY AND DID NOT CUT THE TISSUE. ADDITIONALLY, ON TWO LINEAR RELOADS, IT FIRED BUT DID NOT STAPLE. TO RESOLVE THE ISSUE, RESECTING AND RE-STAPLING WAS DONE AND A NEW LINEAR STAPLERS WAS ALSO USED.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 25060785 ↗
• MalfunctionMay 1, 2026Component or Accessory Incompatibility; Mechanics Altered

  IT WAS REPORTED THAT DURING A COLORECTAL PROCEDURE, THE CIRCULAR STAPLER FIRED BUT IT DID FORM PROPERLY AND DID NOT CUT THE TISSUE. ADDITIONALLY, ON TWO LINEAR RELOADS, IT FIRED BUT DID NOT STAPLE. TO RESOLVE THE ISSUE, RESECTING AND RE-STAPLING WAS DONE AND A NEW LINEAR STAPLERS WAS ALSO USED.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 25060714 ↗
• MalfunctionApr 10, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGECTOMY, AT THE TIME OF GASTRIC TUBE FORMATION, THE DEVICE PARTIALLY FIRED. ANOTHER MANUFACTURER'S DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844268 ↗
• MalfunctionFeb 17, 2026Failure to Fire

  IT WAS REPORTED THAT THE DEVICE DID NOT FIRE. THE PHYSICIAN HAS DECIDED TO CONTINUE USING THE SAME HANDLE WITH THE OTHER RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24371550 ↗
• MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF SEGMENTAL SMALL BOWEL RESECTION, THERE WAS ANASTOMOTIC LEAK.

  Patient problems: Failure to Anastomose

  MAUDE report 22640521 ↗
• MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF SEGMENTAL SMALL BOWEL RESECTION, THERE WAS ANASTOMOTIC LEAK.

  Patient problems: Failure to Anastomose

  MAUDE report 22640494 ↗
• MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF SEGMENTAL SMALL BOWEL RESECTION, THERE WAS ANASTOMOTIC LEAK.

  Patient problems: Failure to Anastomose

  MAUDE report 22640467 ↗
• MalfunctionJul 24, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING SET-UP AND PRIOR TO FIRING ISSUES, THE DEVICE HAD DIFFICULTY OR INABILITY TO CLOSE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588523 ↗
• MalfunctionJul 10, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE TWO LOADING UNITS FAILED TO FIRE. THE DEVICE WAS REPLACED WITH A NEW RELOAD, AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468429 ↗
• MalfunctionJul 10, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE TWO LOADING UNITS EXPERIENCED FIRING ISSUES DURING USE, SPECIFICALLY THAT THE INSTRUMENT FAILED TO FIRE. THE DEVICE WAS REPLACED WITH A NEW RELOAD, AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468400 ↗
• MalfunctionJul 7, 2025Break; Human-Device Interface Problem; Sharp Edges; Break; Human-Device Interface Problem; Sharp Edges

  IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, AFTER FIRING THE LOADING UNIT, ALL THE STAPLES WERE FORMED. HOWEVER, THE KNIFE DID NOT PROPERLY ENGAGE WITH THE WHITE PROTECTIVE COVER DURING RETRACTION, RESULTING IN A NURSE BEING INJURED BY THE UNPROTECTED KNIFE. IT WAS ALSO NOTED THAT THE RELOAD WAS DIFFICULT TO REMOVE FROM THE HANDLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412330 ↗
• MalfunctionMay 6, 2025Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A COLONIC RECUTTING FOR COLOSTOMY CLOSURE, THE DEVICE FIRED ALL THE WAY AND CUT THE COLON DURING THE FIRST PASS, BUT NOT ON THE SECOND PASS. AFTER THE KNOB WAS RETURNED, THE SURGEON PUSHED IT AND THE TISSUE WAS CUT DURING THE PUSH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972278 ↗
• MalfunctionApr 30, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WERE FIRING ISSUES, SPECIFICALLY A PARTIAL FIRE WHERE THE DEVICE DID NOT FIRE COMPLETELY TO THE DISTAL END. THE DEVICE WAS REPLACED WITH ANOTHER 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 21937192 ↗
• MalfunctionApr 3, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO USE, THE RELOAD WAS FOUND TO BE EMPTY. THE ISSUE WAS IDENTIFIED DURING THE SET-UP PHASE BEFORE FIRING. TO RESOLVE THE ISSUE, A NEW LOADING UNIT WAS TAKEN AND THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 21769552 ↗
• MalfunctionMar 26, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING THE USE OF THE GIA 60-3.8SGL LOADING UNIT, THERE WERE FIRING ISSUES WITH THE PRODUCT, THE STAPLER EXPERIENCED A PARTIAL FIRE, IT DID NOT FIRE COMPLETELY TO THE DISTAL END. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER RELOAD. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED, AND THE PATIENT OUTCOME WAS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700967 ↗
• MalfunctionMar 10, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, THE FIRING KNOB COULD NOT BE PUSHED AND THE DEVICE COULD NOT BE FIRED. ANOTHER RELOAD WAS USED BUT DID NOT WORK EITHER. ANOTHER HANDLE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561317 ↗
• MalfunctionJan 29, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE INSTRUMENT DID NOT FIRE. THE DEVICE WAS A GIA6038L GIA 60-3.8SGL USE LOADING UNIT. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW RELOADING UNIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265328 ↗
• MalfunctionNov 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755176 ↗
• MalfunctionNov 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736028 ↗
• MalfunctionNov 10, 2024Fail-Safe Problem; Protective Measures Problem; Fail-Safe Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE KNIFE FELT OUT WHEN THE SURGEON WANTED TO FIRE. THE PROTECTION CAME OUT. THE KNIFE BLADE WAS UNEXPECTEDLY EXPOSED BEFORE USE. AFTERWARDS, THE WHITE FLAG POPPED UP. THE CARTRIDGE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649455 ↗
• MalfunctionOct 3, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT HEMI COLON SURGERY, WHEN CUTTING OFF THE RIGHT END OF THE TRANSVERSE COLON, THE NAIL CANNOT BE STIMULATED. IT WAS NOTED THAT THE DEVICE DID NOT FIRE AND DID NOT CUT THE TISSUE. THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED AT ALL. A NEW STAPLE WAS REINSTALLED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360560 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID RESECTION PROCEDURE, IT WAS DISCOVERED THAT A PORTION OF THE STAPLE LINE IN THE MIDDLE OF THE ANASTOMOSIS HAD A CONTENT LEAK. THE PROCEDURE HAD TO BE CONVERTED TO OPEN SURGERY DUE TO ADHESIONS IN THE BOWEL AND PORT SITE HERNIAS, AS THE PATIENT HAD UNDERGONE PREVIOUS SURGERIES. THIS RESULTED IN A LENGTHY OPERATION. THE SURGEON DECIDED TO STAPLE THE LEFT COLON AND LEAVE THE TRANSECTED PART OF THE BOWEL IN A BOWL, APPLYING A VAC-PAC, TO CONTINUE SURGERY THE FOLLOWING DAY, AS IS DONE IN DAMAGE CONTROL SURGERY. DURING THE CONTINUED SURGERY THE NEXT DAY, THE SURGEON NOTICED THAT ONE CORNER OF THE STAPLE LINE ON THE BOWEL END WAS NOT CLOSED, AS IF 2-3 STAPLES HAD NOT PROPERLY SECURED THE BOWEL LUMEN. IT WAS UNCLEAR WHETHER THIS OCCURRED INTRA-OPERATIVELY OR POST-OPERATIVELY. DUE TO MULTIPLE COMPLICATIONS, INTENSIVE CARE NEEDS, AND A TOTAL OF 10 RE-OPERATIONS, THE SURGEON HAD TO PLACE THIS BOWEL END IN A PERMANENT STOMA BEFORE PATIENT COULD BE DISMISSED AFTER 6 WEEKS IN CARE AT HOSPITAL.

  Patient problems: Adhesion(s); Failure to Anastomose; Tissue Breakdown

  MAUDE report 20267034 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THREE DAYS FOLLOWING A COLORECTAL PROCEDURE WHEREIN A STEEPED SIDE TO SIDE ANASTOMOSIS WAS PERFORMED, THE PATIENT HAD SIGNS OF ANASTOMOSIS LEAKAGE; THE CRP (C-REACTIVE PROTEIN) WAS ELEVATED AND THE CT SCAN SHOWED INTRA ABDOMINAL GAS AND FLUID. TO STOP THE LEAKAGE, THE PATIENT HAD TO UNDERGO ANOTHER SURGERY THE SAME DAY THE SIGNS WERE OBSERVED. IT WAS THEN OBSERVED THAT A PORTION OF THE STAPLE LINE IN THE MIDDLE OF THE ANASTOMOSIS HAD A SMALL CONTENT LEAKAGE. THE PATIENT RECOVERED QUICKLY AFTER THE RE-OPERATION. IT WAS NOTED THAT THE PATIENT HAD PREVIOUSLY BEEN OPERATED ON WITH END-TO-END ANASTOMOSES THAT WERE NOW STENOSED AGAIN - HENCE THE CHOICE OF ANASTOMOSIS TECHNIQUE.

  Patient problems: Failure to Anastomose; Increased Intra-Peritoneal Volume (IIPV); Laceration(s)

  MAUDE report 20259880 ↗
• MalfunctionSep 17, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IT WAS NOT POSSIBLE TO PUSH THE STAPLES AND KNIFE FORWARD. THE SURGEON CHANGED THE LOADING UNIT TWICE WITH THE SAME RESULT, THEN CHANGED THE HANDLE AND THE RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236953 ↗

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-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-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-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-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-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-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-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-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-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-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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT

…and 58 more.