DeRoyal 89-10558Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00749756364430), received between Feb 18, 2022 and Dec 16, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Contamination; Contamination

  A USER FACILITY THROUGH A MEDWATCH, "HAIR ON ASEPTO BULB IN LAPAROTOMY PACK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815362 ↗
• MalfunctionJul 10, 2025Component Missing; Component Missing

  MISSING LAP QUANTITY OF 4 INSTEAD OF 5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467706 ↗
• MalfunctionAug 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR FOUND IMBEDDED IN THE LAP PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928467 ↗
• MalfunctionFeb 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR ON LIGHT HANDLE COVER PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687573 ↗
• MalfunctionJun 27, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR ON PENCIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208132 ↗
• MalfunctionAug 24, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR FOUND INSIDE PACK ON BLUE WRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283136 ↗
• MalfunctionFeb 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PAPER CLIP FOUND INSIDE UNOPENED PACK. PACK WAS NOT OPENED TO REMOVE PAPER CLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559180 ↗