Endo GIA Ultra EGIAUSTNDRecalls & reported problems

Summary

The FDA's MAUDE database contains 9,730 adverse event reports that list this exact device (DI 10884523003543), received between Feb 2, 2016 and Sep 30, 2026 — classified as 5 deaths, 506 injuries, 9,219 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (6,179 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825); 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 9,730 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Retraction Problem

  It was reported that during a thoracoscopic lobectomy for a pulmonary nodule, while cutting using the stapler, staples fired abnormally, staples failed to form, and the stapler was difficult to retract, which impeded the procedure. A new stapler were used to complete the surgery, and the patient returned safely to the ward. The event resulted in a second intraoperative incision and increased bleeding and surgical risks.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50941771 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: Insufficient Information

  MAUDE report 50937066 ↗
• MalfunctionSep 29, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936784 ↗
• MalfunctionSep 29, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935559 ↗
• MalfunctionSep 29, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934071 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: Laceration(s)

  MAUDE report 50923741 ↗
• MalfunctionSep 28, 2026Failure to Fire

  According to the reporter, intra-operatively of a laparoscopic appendectomy, during the transection of the ileocecal region, the sur geon was able to press the green button and squeeze the handle, but the device did not fire. Another device was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912259 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter, during a partial lung resection, at the time of parenchymal resection, the lung parenchyma was clamped with a black reload, and an attempt was made to fire, but the staple did not advance. It was noted that the staple came out around the proximal side of the cartridge's jaw. The cartridge and handle were replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864737 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter, during a procedure, two handles could not be squeezed and the device failed to fire despite the jaw being completely closed, after which manual suturing was performed as a staple line replacement. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864532 ↗
• MalfunctionSep 23, 2026Misfire

  According to the reporter, during a laparoscopic appendectomy procedure, the knife advanced first. A new handle and reload were used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864473 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter, during a procedure, two handles could not be squeezed and the device failed to fire despite the jaw being completely closed, after which manual suturing was performed as a staple line replacement. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864420 ↗
• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter during a gastric bypass procedure, the manual handle with reload did not fire. The surgeon was able to press the green safety button but was unable to squeeze the handle. The handle and reload were replaced to resolve the issue and the procedure was extended by approximately 15 minutes to complete the procedure. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863179 ↗
• MalfunctionSep 23, 2026Human-Device Interface Problem

  It was reported that during a laparoscopic pulmonary resection procedure, the stapler was unable to fire. The surgeon was unable to press the green button or squeeze the handle. The product 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 50863157 ↗
• MalfunctionSep 22, 2026Entrapment of Device

  Patient problems: Insufficient Information

  MAUDE report 50859480 ↗
• MalfunctionSep 22, 2026Failure to Fire

  It was reported that pre-operatively, manual handle did not fire despite the surgeon being able to press the green safety button and squeeze the handle. The device was replaced with the same product.

  Patient problems: Insufficient Information

  MAUDE report 50849739 ↗
• MalfunctionSep 21, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846238 ↗
• MalfunctionSep 21, 2026Failure to Fire

  It was reported that during a colonic resection and anastomosis procedure requiring surgical stapling, the two had manual handles had trigger issues. The handles could not be squeezed, and stapling could not be performed. The two staplers were 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 50841707 ↗
• MalfunctionSep 21, 2026Noise, Audible

  According to the reporter, during a laparoscopic cholecystectomy, the firing was performed without issue but an abnormal sound was heard. No treatment intervention was necessary, and the issue was considered resolved without additional action. There was no patient injury. Medtronic's initial evaluation of the incident device found that the sheared teeth damage was confirmed from the 1st, 2nd, 4th, 5th, 6th, and 7th on the firing rack.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838377 ↗
• MalfunctionSep 18, 2026Entrapment of Device; Firing Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50823379 ↗
• MalfunctionSep 18, 2026Misfire; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50822850 ↗
• MalfunctionSep 18, 2026Failure to Fire

  According to the reporter, intra-operatively, the device did not fire. The surgeon was able to press the green button but was unable to squeeze the handle. Another device was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820743 ↗
• MalfunctionSep 18, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820626 ↗
• MalfunctionSep 17, 2026Misfire

  Misfire of the stapler.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802742 ↗
• MalfunctionSep 12, 2026Failure to Fire

  Patient problems: Insufficient Information

  MAUDE report 50745305 ↗
• MalfunctionSep 12, 2026Break; Entrapment of Device; Retraction Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50744673 ↗

Recalls under the same FDA submission

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

• 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-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-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-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-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-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-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-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-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-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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT

…and 58 more.