DeRoyal 89-10561Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756363723), received between Jul 21, 2021 and Aug 25, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 reports).

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

• MalfunctionAug 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A USER FACILITY REPORTED, "AFTER COMPLETELY SETTING UP FIELD, BUT BEFORE PATIENT IN THE ROOM, TURNED OVER A BLUE TOWEL THAT CAME IN THE LAPAROSCOPY PACK, NOTICED DEBRIS ON IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885170 ↗
• MalfunctionAug 2, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A HAIR WAS FOUND IN DEROYAL CMC LAPAROSCOPY PACK DURING PROCEDURE SETUP. IT IS BELIEVED THAT IT CAME FROM THE PACK. PACK DISCARDED AND STERILE FIELD WAS RESET. (CMC LAPROSCOPY PACK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258391 ↗
• MalfunctionJul 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  BLACK SPECS ON COMPONENTS (CMC LAPAROSCOPY PACK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12205004 ↗