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Washing Case Maj-827

by Olympus Medical Systems Corporation 2 variants

Washing Case Maj-827 (6808900), a sterilizer/disinfector rack (FDA Class II; FDA product code FEB, Accessories, Cleaning, for Endoscope) made by Olympus Medical Systems Corporation, was cleared under FDA 510(k) K120357 on 20 Dec 2012 (1 earlier submission) and listed in FDA GUDID on 21 Sep 2016 (UDI-DI 04953170069512); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026. FDA recalls on record: 8.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170069512 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120357 Date20 Dec 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120357 decided 20 Dec 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04953170069512 listed 21 Sep 2016 Listed

Recalls

8 recalls · 7 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.

  • 2 recalls, same reason

    • Ongoing Z-0873-2026 FDA Class II initiated 31 Oct 2025
    • Ongoing Z-0874-2026 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.

  • 2 recalls, same reason

    • Ongoing Z-2342-2023 FDA Class II initiated 26 May 2023
    • Ongoing Z-2343-2023 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.

Timeline

11 dated events

  1. Cleared FDA 510(k) K120357
  2. Recall initiated FDA recalls Z-0138-2017
  3. Listed FDA GUDID 04953170069512
  4. Recall initiated FDA recalls Z-2342-2023
  5. Recall initiated FDA recalls Z-2343-2023
  6. Recall initiated FDA recalls Z-2447-2023
  7. Recall initiated FDA recalls Z-1009-2024
  8. Recall initiated FDA recalls Z-0873-2026
  9. Recall initiated FDA recalls Z-0874-2026
  10. Recall initiated FDA recalls Z-1613-2026

1 earlier event are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Washing Case
Generic name
Sterilizer/disinfector rack
Model / Ref / Catalog
MAJ-827, 6808900
Primary DI / UDI-DI
04953170069512
FDA product code
FEB
GMDN term
Sterilizer/disinfector rack
Device class
Class II
Regulation number
876.1500
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K103264)

and 8 more cleared under K103264

Cleared under the same submission (K120357)

and 8 more cleared under K120357

Similar devices

Other devices filed under FDA product code FEB (ACCESSORIES, CLEANING, FOR ENDOSCOPE).

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 (12, all answered No)