Stablecut® 11-3539Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024493933), received between May 9, 2023 and May 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

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 16, 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.

• MalfunctionMay 9, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A FOREIGN OBJECT SUCH AS HAIR WAS FOUND IN THE PACKAGING OF THE PRODUCT. THE EVENT OCCURRED DURING SURGERY HOWEVER THERE WAS NO HARM REPORTED TO THE PATIENT. UPON COMPLETION OF INVESTIGATION, IT WAS UNKNOWN IF THE PACKAGING MET SPECIFICATION. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894613 ↗