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DeRoyal D6201Recalls & reported problems

Deroyal Industries, Inc. · Blade, Carbon Steel · Class 1

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756144520), received between Jan 8, 2021 and Jan 19, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break3
  • Material Integrity Problem3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 19, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

    THE BLADES ARE BREAKING, SOME INSIDE PATIENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11195095 ↗
  • MalfunctionJan 19, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

    THE BLADES ARE BREAKING, SOME INSIDE PATIENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11195093 ↗
  • MalfunctionJan 8, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

    THE SCALPEL BROKE WHILE BEING USED ON A PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11141195 ↗

Other BLADE, SCALPEL devices

All BLADE, SCALPEL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.