AIR FILTER MAJ-823Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170069475), received between Aug 24, 2023 and Jul 1, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).

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

• MalfunctionJul 1, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED, THAT THE GAS FILTER WAS USED PAST ITS REPLACEMENT DATE OF ONE MONTH. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373800 ↗
• MalfunctionAug 24, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE AIR FILTER HAD WATER ENTER DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS EVALUATED, AND IT WAS FOUND THAT IT IS UNCLEAR WHAT KIND OF WATER WAS ENTERING VIA THE LEAKING CHECK VALVE, WHICH COULD OF AFFECTED REPROCESS ABILITY. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610637 ↗

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-1900-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
• Z-1909-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
• Z-1906-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
• 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-1905-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
• 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-1899-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
• Z-1908-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
• Z-1904-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
• Z-1901-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
• Z-1902-2026 · Mar 25, 2026 · Open, Classified
  OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
• 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.