DeRoyal 89-10544Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756366342), received between Apr 20, 2023 and Jun 25, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. Apr 17, 2023Open, Classified

   The custom procedure packs contain light handle covers that have been recalled by another firm.

   Z-1691-2023 · Root cause: Nonconforming Material/Component · 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.

• MalfunctionJun 25, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR FOUND IN LAPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607664 ↗
• MalfunctionApr 20, 2023Material Puncture/Hole; Material Puncture/Hole

  HOLE IN OUTER PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775418 ↗