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Open, Classified

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

FDA Recall Z-1611-2026 · Posted 2026-03-20

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeODC
Date Initiated2026-02-12
Product Quantity89,579 units

Reason for Recall

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

Firm Action

Olympus notified consignees on about 02/12/2026 via URGENT: MEDICAL DEVICE CORRECTION letter. Consignees were instructed to immediately cease reprocessing the MAJ-1443 and MAJ-1444 valves in an OER-Pro or OER-Elite and ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the full extent of the MAJ-1443 and MAJ-1444 reprocessing steps as detailed in the provided Instructions for Use (IFU). The updated IFU can also be accessed electronically through OlympusConnect.com. Additionally, consignees were instructed to replace any existing copies of the MAJ-1443/MAJ-1444 IFU with the updated IFU provided in this letter, identify and notify all customers if affected units were further distributed and complete and confirm receipt of the notification via the Olympus web portal.

Root Cause

Reprocessing Controls

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation · 2025-07-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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