DeRoyal 89-10570Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00749756363587), received between Aug 2, 2021 and Mar 21, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEAD INSECT FOUND INSIDE THE STERILE PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954130 ↗
• MalfunctionMar 20, 2023Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

  RAYTECS IN POSTERIOR SPINE PACK FAULTY, THE X-RAY DETECTABLE STRIP IS EASILY REMOVED FROM RAYTEC SPONGE. STRING CAME OUT WHILE CLEANING KERRISON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573720 ↗
• MalfunctionDec 7, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR IN PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931383 ↗
• MalfunctionMay 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PACK CONTAMINATED WITH A BLACK HAIR INSIDE THE BASIN UNDER THE TAB WITH THE RAYTEC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453088 ↗
• MalfunctionAug 2, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A STRAND OF HAIR WAS FOUND IN THE POSTERIOR SPINE PACK AFTER IT WAS OPENED. HAIR WAS DISCOVERED UNDER THE BLUE TOWEL THAT SITS ON TOP OF THE GOWN IN THE PACK; PACK WAS DISCARDED, HAIR WAS NOT SAVED, NO PICTURE WAS TAKEN. (CMC POSTERIOR SPINE PACK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258376 ↗