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-1898-2026
- Brand
- Olympus of the Americas
- Classification
- Class II
- Units affected
- 9,757 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
Affected products
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 Number: MAJ-2110. UDI Number: 04953170404054. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 2XA, 2YA, 2ZA, 31A, 32A, 33A, 34A, 35A, 36A, 37A, 38A, 39A, 3XA, 3YA, 3ZA, 41A, 42A, 43A, 44A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 4ZA, 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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