DeRoyal 89-10581Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00749756366304), received between Aug 2, 2021 and Aug 25, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (21 reports).

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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

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

  A USER FACILITY REPORTED, "SPOT NOTED ON TABLE DRAPE AFTER OPENING PACK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885171 ↗
• MalfunctionJun 3, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR WAS NOTED ON THE END OF THE BOVIE PENCIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132903 ↗
• MalfunctionJan 3, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PITCHER HAD BLACK SPOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086302 ↗
• MalfunctionDec 9, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  BLACK SPECK IN BOWL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949360 ↗
• MalfunctionNov 30, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CONTAMINANT ON SUCTION TUBING OF STERILE DEROYAL VASCULAR PACK, NOTED ON THE SUCTION TUBING FOUND INSIDE THE STERILE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886041 ↗
• MalfunctionNov 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUBSTANCE ON TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876858 ↗
• MalfunctionNov 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUBSTANCE ON TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876843 ↗
• MalfunctionNov 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUBSTANCE ON TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876816 ↗
• MalfunctionNov 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ORANGE SUBSTANCE ON TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876811 ↗
• MalfunctionNov 28, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUBSTANCE ON TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869521 ↗
• MalfunctionNov 28, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUBSTANCE ON TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869508 ↗
• MalfunctionAug 11, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  RED SUBSTANCE ON SUCTION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209582 ↗
• MalfunctionMay 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  RED SUBSTANCE ON TUBING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14304181 ↗
• MalfunctionMay 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  RED SUBSTANCE ON TUBING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14304036 ↗
• MalfunctionMar 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEBRIS FOUND IN BUCKET WITH HANDLE. NEW PACK OBTAINED BEFORE PATIENT ENTERED THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652846 ↗
• MalfunctionMar 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUCTION TUBING CONTAMINATED WITH RED DEBRIS. NEW PACK OBTAINED BEFORE PATIENT ENTERED THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652839 ↗
• MalfunctionMar 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUCTION TUBING WITH RED DEBRIS. DISCOVERD BEFORE PATIENT ENTERED THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652837 ↗
• MalfunctionFeb 22, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CONMED TUBING IS STAINED WITH SUBSTANCE. THIS PACK WAS REMOVED FROM THE ROOM PRIOR TO PATIENT ENTERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578073 ↗
• MalfunctionFeb 8, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  UPON INSPECTION, THE SUCTION TUBE WAS DISCOLORED WITH RED FOREGIN OBJECT IN IT. THE STERILE FIELD WAS BROKEN DOWN AND REOPENED PRIOR BEFORE THE PATIENT ENTERED THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480010 ↗
• MalfunctionDec 28, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  BROWNISH SUBSTANCE ON THE CONMED TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095112 ↗
• MalfunctionAug 2, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEROYAL VASCULAR PACK. THERE WAS DEBRIS FOUND IN THE PACK, I HAVE THE BASIN WITH SOME OF THE DEBRIS IN IT. THE PATIENT WAS NOT IN THE ROOM, THE PACK WAS REMOVED, AND A NEW PACK WAS OPENED PRIOR TO THE PATIENT ENTERING THE ROOM. (CMC VASCULAR PACK)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258388 ↗