Medline CISION15CSRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30193489090196), received between May 22, 2026 and May 22, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 18, 2022Open, Classified

   Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.

   Z-0930-2023 · Root cause: Under Investigation by firm · FDA record ↗

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 22, 2026Dull, Blunt

  IT WAS REPORTED THAT THE BLADES CAME IN DULL.

  Patient problems: Insufficient Information

  MAUDE report 25262788 ↗