RETAINING RACK MAJ-840Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170069611), received between Jan 10, 2023 and Jan 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2023Component Missing; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS, THE RETAINING RACK HAD A BUTTON POPPED OFF OF THE BUTTON CASE, MAKING IT SO SETTINGS COULD NOT BE ADJUSTED. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131556 ↗

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