DeRoyal 89-10560Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00749756363778), received between Jan 10, 2022 and Aug 25, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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

  A USER FACILITY REPORTED, "HAIR ON MEDICATION SHEET IN LAPAROTOMY PACK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885169 ↗
• MalfunctionJun 2, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR INSIDE SPECIMEN CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124940 ↗
• MalfunctionMay 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR FOUND IN SINGLE USE DISPOSABLE DEVICE. HAIR FOUND INSIDE THE BOVIE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059967 ↗
• MalfunctionNov 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR IN STERILE SUPPLY. IT WAS DETERMINED TO BE IN THE BASIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632537 ↗
• MalfunctionMay 3, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  RED DISCOLORATION ON THE LEFT SIDE OF PACK WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859687 ↗
• MalfunctionMar 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  UNIDENTIFIED SPECS FOUND ON BACK TABLE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496345 ↗
• MalfunctionFeb 17, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEBRIS WAS FOUND ON THE STERILE BUCKET INSIDE THE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396400 ↗
• MalfunctionJan 10, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  UNIDENTIFIED, BLACK MATERIAL NOTED IN BASINS IN PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132085 ↗
• MalfunctionJan 10, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR IN PAPER TOWEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131100 ↗
• MalfunctionDec 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR IN BASIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931273 ↗
• MalfunctionNov 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUBSTANCE ON TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876842 ↗
• MalfunctionAug 23, 2022Material Puncture/Hole; Material Puncture/Hole

  RIP IN OUTER BLUE WRAP OF PACK. PACK REMOVED FROM ROOM. NEW PACK OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276677 ↗
• MalfunctionMar 23, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  LONG HAIR FOUND IN LAPAROTOMY PACK. PACK REMOVED FROM ROOM. SCRUB PERSON CHANGED AND A NEW PACK WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861985 ↗
• MalfunctionFeb 8, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CONMED TUBING HAS BROWN STREAKS ON THE OUTSIDE OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480001 ↗
• MalfunctionJan 10, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A BLACK HAIR WAS FOUND ON THE DRAPE IN THE (CMC LAPAROTOMY PACK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13207442 ↗