DeRoyal D4511ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00749756645386), received between Oct 11, 2018 and Jun 25, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Dull, Blunt

  A DISTRIBUTING FACILITY REPORTED, "WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING DULL INSTRUMENTS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620320 ↗
• MalfunctionMar 14, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ON (B)(6) 2023 WE HAD AN INJURY AT THE ROI CPS, LLC FACILITY DUE TO A BLADE BECOMING EXPOSED PRIOR TO USE.

  Patient problems: Laceration(s)

  MAUDE report 18905548 ↗
• MalfunctionJun 6, 2019Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  EMPLOYEES WERE CUT FROM THE SCALPEL BLADE WHEN OPENING CASES. SOME BLADES WERE EXPOSED AND NOT LOCKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674520 ↗
• MalfunctionNov 21, 2018Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  BLADE IS NOT SECURE IN SCALPEL AND IS STICKING OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096468 ↗
• MalfunctionOct 11, 2018Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  THE BLADE IS LOOSE, NOT SECURED INSIDE THE SCALPEL.

  Patient problems: No Patient Involvement

  MAUDE report 7957494 ↗
• MalfunctionOct 11, 2018Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  THE BLADE WAS LOOSE, NOT SECURED INSIDE THE SCALPEL.

  Patient problems: No Patient Involvement

  MAUDE report 7957478 ↗
• MalfunctionOct 11, 2018Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  THE BLADE WAS LOOSE, NOT SECURED INSIDE THE SCALPEL.

  Patient problems: No Patient Involvement

  MAUDE report 7957473 ↗