Medline CISION15CSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30193489090189), received between Sep 25, 2026 and Sep 29, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  It was reported that "In 2 separate cases today I had the scalpel blade I was using fracture during incision."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933787 ↗
• MalfunctionSep 25, 2026Material Discolored

  It was reported that Blades turning black upon contact with chemicals.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899111 ↗