Stablecut® 11-3542Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024493964), received between May 19, 2023 and May 19, 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. How this data works · Data updated Oct 13, 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 19, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED BY JAPAN WAREHOUSE ZB PERSONNEL THAT ON MAY 1, 2023 DURING INCOMING INSPECTION THE TEAM MEMBER FOUND A HAIR LIKE DEBRIS IN THE STERILE PACKAGE. NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961252 ↗