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DeRoyal 5-18129-ACSRecalls & reported problems

Deroyal Industries, Inc. · PREP TRAY NO GLOVES NON STERILE · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756864848), received between Mar 20, 2023 and Mar 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Loss of or Failure to Bond1
  • Material Integrity Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 20, 2023Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

    THE SPONGE PORTION OF SPONGE STICK IN THE PREP TRAY FELL OFF IN THE PATIENT WHILE PREPPING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16573687 ↗

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Sources and updates

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