FDAClass II · Medical device · Recalled April 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall — Olympus Corporation of the Americas

Hazard: Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1904-2026
Brand: Olympus of the Americas
Classification: Class II
Units affected: 373 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

Affected products

OER-ELITE Endoscope Reprocessor Connecting Tubes

Companies & origin

Recalling firm location: Center Valley, PA, United States
Firm address: 3500 Corporate Pkwy, N/A, 18034-8229

Identifying details (verbatim from the notice)

Product codes / lots: Model: MAJ-2116. UDI Number: 04953170404115. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 25A, 26A, 27A, 28A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A.
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Firm notified the public via: Letter
FDA event ID: 98544
Recall initiated: March 25, 2026
FDA classified: April 22, 2026
FDA report date: April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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