ECHELONRecalls & reported problems across all models

We found 10 models of ECHELON by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 2,011 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2022 and Sep 30, 2026 — classified as 3 deaths, 154 injuries, 1,854 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (781 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ECHELON problems

ECHELON models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ECHELON ECH60S

  Stapler, surgical
  1 death631 reports
• ECHELON ECH60L

  Stapler, surgical
  467 reports
• ECHELON ECH45S

  Stapler, surgical
  269 reports
• ECHELON GCS40G

  Staple, implantable
  2 deaths219 reports
• ECHELON ECH60C

  Stapler, surgical
  197 reports
• ECHELON ECH45C

  Stapler, surgical
  138 reports
• ECHELON GCS40B

  Staple, implantable
  49 reports
• ECHELON ECH45L

  Stapler, surgical
  33 reports
• ECHELON GCR40G

  Staple, implantable
  7 reports
• ECHELON GCR40B

  Staple, implantable
  1 report

Recent ECHELON adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947930 ↗
• MalfunctionSep 30, 2026Failure to Fire

  It was reported that during a Pelvic mass cystourethroscopy the use of the device in the operating room, the following failure occurred:¿ When using the contour it failed, did not fire and disassembled.Was there any harm to the reported patient or user? No

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947229 ↗
• MalfunctionSep 29, 2026Failure to Fire

  It was reported that during a Rectosigmoidectomy that tissue was being cut without stapling, making it impossible to restart the reconstruction of intestinal transit.Was there any damage or injury reported by the patient or user? Unknown Was there a significant delay? Unknown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931620 ↗
• MalfunctionSep 28, 2026Positioning Failure; Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923848 ↗
• MalfunctionSep 28, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923820 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923795 ↗
• MalfunctionSep 28, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922662 ↗
• MalfunctionSep 28, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922482 ↗
• MalfunctionSep 28, 2026Failure to Fire

  It was reported that, during Video-Assisted Thoracic Surgery for the lung resection, the device could not activate and the knife did not move when the tissue was grasped and fired. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available. r.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920895 ↗
• MalfunctionSep 28, 2026Difficult to Open or Close; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920027 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917446 ↗
• MalfunctionSep 28, 2026Failure to Fire

  It was reported that, during an unknown respiratory surgery, the device did not activate due to battery discharge or a poor connection. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917407 ↗
• MalfunctionSep 28, 2026Failure to Form Staple; Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917279 ↗
• MalfunctionSep 25, 2026Difficult to Open or Close

  It was reported that during an Lap Appendectomy, the ECH60S with white reload was was fired and stapled and cut. then hepatics were felt and they could not open jaw, The manual release was used to bring back knife blade and open stapler. No other stapler was needed to complete. There was no patient consequence reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899433 ↗
• MalfunctionSep 25, 2026Failure to Form Staple; No Apparent Adverse Event

  It was reported that during an Unknown surgery, after fired, noted some staples malformed with irregular shape. And then the staple line and cut line are both complete. noted oozing. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896166 ↗

Other Ethicon Endo-Surgery, LLC products

• Harmonic ACE9 models · 12,862 reports
• ECHELON FLEX7 models · 9,393 reports · 1 recall
• Harmonic13 models · 8,752 reports · 2 recalls
• ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
• LIGACLIP26 models · 3,254 reports
• ENDOPATH37 models · 2,785 reports
• ECHELON CIRCULAR4 models · 2,532 reports
• ECHELON Flex ENDOPATH7 models · 2,334 reports