WATER FILTER MAJ-824Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170069482), received between Mar 22, 2023 and Sep 4, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (5 reports).

16 other recalls cover devices cleared under the same FDA submission (K201920); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THAT THE WATER FILTER WAS SUSPECTED OF POOR REPROCESSING, DUE TO INADEQUATE WATER FILTER HANDLING OR INADEQUATE WATER SUPPLY PIPING DISINFECTION. AFTER WATER FILTER REPLACEMENT WERE USED FOR THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138214 ↗
• MalfunctionSep 4, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE WATER FILTER WAS SUSPECTED OF POOR REPROCESSING DUE TO INADEQUATE WATER FILTER HANDLING OR INADEQUATE WATER SUPPLY PIPING DISINFECTION AFTER WATER FILTER REPLACEMENT WERE USED FOR THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138129 ↗
• MalfunctionSep 4, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE WATER FILTER WAS SUSPECTED OF POOR REPROCESSING DUE TO INADEQUATE WATER FILTER HANDLING OR INADEQUATE WATER SUPPLY PIPING DISINFECTION AFTER WATER FILTER REPLACEMENT WERE USED FOR THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138048 ↗
• MalfunctionFeb 26, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE WATER AND AIR FILTER WAS NOT REPLACED ON SCHEDULE. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777512 ↗
• MalfunctionDec 29, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED THAT THE REPROCESSOR GAVE AN ERROR INDICATING AN IRREGULARITY IN CIRCUITRY (E83). DURING INSPECTION OF THE REPROCESSOR, EXAMINATION SHOWED THE WATER FILTER (PART NUMBER MAJ-824) HAD NOT BEEN REPLACED SINCE 2021. THE DEVICE INSTRUCTIONS FOR USE FOR THE REPROCESSOR STATES MONTHLY REPLACEMENT OF THIS FILTER IS REQUIRED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419655 ↗
• MalfunctionMay 27, 2023Malposition of Device; Malposition of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THAT SINCE CHANGING THE WATER FILTER, THE USER FACILITY HAS BEEN EXPERIENCING AN EXTENDED WASH TIME OF UP TO 40 MINUTES WHEN USING THE ENDOSCOPE REPROCESSOR. THIS HAS NOT BEEN ISOLATED TO ONE SCOPE. THE GAUGE OF THE WATER SYSTEM SHOWED NO PRESSURE. THE WATER SUPPLY WAS AT A VERY LOW PRESSURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6) WATER FILTER) AND (B)(6) (OER-ELITE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015597 ↗
• MalfunctionMar 22, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), DURING REPROCESSING, IT WAS NOTED, THE WATER FILTER WAS NOT REPLACED FOR A LONG PERIOD OF TIME (ABOUT A YEAR). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. PATIENT IDENTIFIER (B)(6) CAPTURES THE COMPLAINT ON THE REPROCESSOR USED WITH THE WATER FILTER (MODEL: OER-PRO, SERIAL NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590075 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201920. One submission often covers many models, so check the product and lot details in each record.

• Z-1905-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
• Z-1906-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
• Z-1904-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
• Z-1899-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
• Z-1898-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
• Z-1900-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
• Z-1907-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
• Z-1903-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
• Z-1902-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
• Z-1901-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
• Z-1909-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
• Z-1908-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
• Z-1612-2026 · Feb 12, 2026 · Open, Classified
  Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
• Z-0872-2026 · Oct 31, 2025 · Open, Classified
  Olympus OER-Elite
• Z-2344-2023 · May 26, 2023 · Open, Classified
  Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

…and 1 more.