GIA GIA6025LRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884523007206), received between Aug 9, 2016 and Nov 5, 2025 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (17 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE BLADE WAS STICKING OUT. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW PRODUCT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476320 ↗
• MalfunctionOct 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE OPEN STAPLER DID NOT FIRE DURING SET-UP. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23298206 ↗
• MalfunctionJun 30, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364621 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE AFTER THE RELOADS WAS FIRED IN THE JEJUNUM BOTH RELOAD HAD A STAPLE LINE BLEEDING, WHILE THE 2.5 MM ALSO HAD A STAPLE LINE CONTENT LEAK. SUTURING WAS DONE ON BOTH STAPLE LINE AS REINFORCEMENT. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES DUE TO THE ISSUE THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Tissue Breakdown

  MAUDE report 20138494 ↗
• MalfunctionAug 20, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS NOT ABLE TO FIRE. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007510 ↗
• MalfunctionJul 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE PARTIALLY FIRED. THE DEVICE DID NOT FIRE COMPLETELY TO THE DISTAL END. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720928 ↗
• MalfunctionApr 23, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY,  THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164833 ↗
• MalfunctionNov 16, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 18156084 ↗
• MalfunctionSep 19, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN ILEOSTOMY, THE SURGEON TRIED TO FIRE, BUT THERE WAS A PROBLEM WITH THE BLADE. THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775090 ↗
• MalfunctionJun 2, 2023Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054468 ↗
• MalfunctionMay 18, 2023Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROTOMY LIVER RESECTION, AFTER FIRING, WHEN AN ATTEMPT WAS MADE TO RETURN THE KNIFE, THE SAFETY ENGAGED, BUT THE KNIFE STOPPED HALFWAY AND DID NOT RETURN UNTIL THE PROXIMAL SIDE. NOTHING IN PARTICULAR WAS DONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953472 ↗
• MalfunctionMay 12, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. THE LOADING UNIT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924310 ↗
• MalfunctionApr 27, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL GASTRECTOMY, THE RELOAD DID NOT 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 16828552 ↗
• MalfunctionNov 29, 2022Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, WHILE CHECKING TO USE THE PRODUCT, THE BLADE WAS ALREADY PROTRUDING OUTWARDS. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15881185 ↗
• MalfunctionOct 14, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611457 ↗
• MalfunctionSep 23, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT FIRE. THE SURGEON USED ANOTHER NEW RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470970 ↗
• MalfunctionAug 10, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201388 ↗
• MalfunctionJun 21, 2022Misfire; Insufficient Device Problem Information; Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING OPEN LIVER RESECTION, AT HEPATIC VEIN TREATMENT, THE PRELOADED CARTRIDGE WORKED FINE BUT THE ADDITIONAL RELOAD WAS PARTIALLY FIRED - THE STAPLE WAS FOUND TO BE COMING OUT WHEN THE HANDLE WAS OPENED. ANOTHER HANDLE AND RELOAD WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758059 ↗
• MalfunctionMar 8, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE WAS NOT ABLE TO FIRE. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694139 ↗
• MalfunctionDec 20, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE STAPLES DID NOT DEPLOY OR COME OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043356 ↗
• MalfunctionMay 25, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11875868 ↗
• InjuryApr 5, 2021Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, THE STAPLES DID NOT DEPLOY DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11613294 ↗
• MalfunctionMar 10, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT FIRE. THE STAPLE DID NOT COME OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453614 ↗
• MalfunctionJan 5, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE PARTIALLY FIRED. REPLACED THE DEVICES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 11117237 ↗
• MalfunctionDec 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, A COMPONENT OF THE DEVICE DISENGAGED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11074121 ↗

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-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-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-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-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-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-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-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-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-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-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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

…and 58 more.