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Leak Test Air Tube Maj-1905

by Olympus Medical Systems Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

5 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Overview

A device designed to test the integrity of an endoscope's air tube, providing a reliable and effective solution for leak testing. This comprehensive guide provides in-depth information on its features, regulatory compliance, and usage instructions.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170299360 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

6 recalls · 5 ongoing · FDA

    • Ongoing Z-1613-2026 FDA Class II initiated 12 Feb 2026

    The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

    • Ongoing Z-0873-2026 FDA Class II initiated 31 Oct 2025

    Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

    • Ongoing Z-1009-2024 FDA Class II initiated 16 Jan 2024

    Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.

    • Ongoing Z-2447-2023 FDA Class II initiated 12 Jul 2023

    The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

    • Ongoing Z-2342-2023 FDA Class II initiated 26 May 2023

    Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

    • Terminated Z-0138-2017 FDA Class II initiated 23 Jun 2016

    New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Leak Test Air Tube
Generic Name
Endoscope leak tester tubing
Model / Reference
MAJ-1905
Primary DI / UDI-DI
04953170299360
FDA Product Code
FEB
GMDN Term
Endoscope leak tester tubing
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K103264)

Show all (12)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No