Diego Elite HSDHP200TRAYRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925035669), received between Aug 4, 2022 and Aug 4, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Residue After Decontamination” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED THAT THE RESIDUAL WATER ON THE DEVICE TRAY CANNOT DRAIN WATER PROPERLY AFTER CLEANING DUE TO TOO MUCH SURFACE AND FEW HOLES IN THE FILTER BASKET. IT WAS NOTED , AS A RESULT, WATER CAN REMAIN IN THE SCREENS THAT CAN LEAD TO CONTAMINATION AND POTENTIAL HAZARDS TO PATIENTS. THEREFORE, USER WILL USE ITS OWN TRAYS. IT WAS NOTED THAT THE SUBJECT TRAY WAS NOT EVEN USED. THE ISSUE FOUND DURING RECEIPT INSPECTION. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161937 ↗