LEAK TEST AIR TUBE MAJ-2127Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170404160), received between Oct 30, 2023 and Sep 24, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K190969); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED, THE CONNECTORS OF THE LEAK TEST AIR TUBE WERE BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297725 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED, THE CONNECTORS OF THE LEAK TEST AIR TUBE WERE BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237282 ↗
• MalfunctionMar 4, 2024Break; Break

  IT WAS REPORTED, THE CONNECTORS ON THE LEAK TEST AIR TUBE KEPT BREAKING. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827080 ↗
• MalfunctionOct 30, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT WHILE REPROCESSING VARIOUS OLYMPUS CONNECTING TUBES, THE CLIPS BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT DURING THESE EVENTS. THIS REPORT IS 3 OF 14. PLEASE SEE THE FOLLOWING PATIENT IDENTIFIERS FOR THE RELATED EVENTS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029321 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190969. One submission often covers many models, so check the product and lot details in each record.

• Z-0638-2022 · Dec 13, 2021 · Terminated
  OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessor