Echelon Linear Cutter GLCR100BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705036027850), received between Dec 12, 2024 and May 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (1 report).

1 other recall cover devices cleared under the same FDA submission (K223760); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD HAD SOME STAPLES LEFT THAT DIDN¿T DEPLOY AFTER THE SURGEON USED IT IN THE PROXIMAL END. PATIENT WAS NOT HARMED, AND SURGERY WAS COMPLETED SUCCESSFULLY. THEREFORE, THE CREATION OF A NEW COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960392 ↗
• MalfunctionDec 12, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A COLON PROCEDURE THE SURGEON SAID WHEN USING THE STAPLER, IT DID NOT CLIP PROPERLY. THEY ENDED UP DOING AN OSTOMY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20915514 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223760. One submission often covers many models, so check the product and lot details in each record.

• Z-0147-2026 · Sep 11, 2025 · Open, Classified
  ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80