JustRight5mm Reload JR-REL25-2.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00865163000119), received between Dec 29, 2025 and Dec 29, 2025 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PHYSICIAN REPORTED THAT DURING A JUSTRIGHT STAPLER PROCEDURE THE STAPLE LINE DID NOT FULLY DEPLOY AFTER CLAMPING THE TISSUE AND FIRING THE STAPLE LINE. PHYSICIAN REPORTED THAT ABOUT HALF OF THE STAPLE LINE HAD DEPLOYED AND A COUPLE OF THE STAPLES HAD NOT FORMED. PHYSICIAN USED A SECOND LINE AND OBSERVED THE SAME BEHAVIOR. ON A CALL WITH A HOLOGIC REPRESENTATIVE IT WAS REPORTED THAT THE TISSUE LOOKED SWOLLEN, THE PROCEDURE WAS COMPLETED WITH ANOTHER MODALITY. NO PATIENT INJURY WAS REPORTED AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THE PART THAT WAS BEING TREATED WAS THE PROXIMAL ESOPHAGUS (ZENKER´S INTERPARTY WALL) , AND INCLUDED THE CRICOPHARYNGEUS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure to Anastomose

  MAUDE report 23914419 ↗