DeRoyal 89-5525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756640473), received between Sep 17, 2018 and Oct 22, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2018Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem; Device Misassembled During Manufacturing /Shipping; Manufacturing, Packaging or Shipping Problem

  THE CONVENIENCE KIT CONTAINED SEVEN SPONGES WHEN THERE ONLY SHOULD HAVE BEEN FIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990250 ↗
• MalfunctionSep 17, 2018Packaging Problem

  A PERCUTANEOUS TRAY PACK WAS OPENED. INSIDE THE PACK, THERE WERE 7 SMALL SPONGES WHEN THERE SHOULD HAVE ONLY BEEN 5. THE SMALL SPONGES WERE REMOVED FROM THE FIELD AND PLACED IN A BAG WITH THE PACKAGING LABEL FOR THE PACK AND GIVEN TO THE CHARGE NURSE.

  Patient problems: No Information

  MAUDE report 7880956 ↗