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FDAClass II · Medical device · Recalled July 15, 2026

Olympus Single Use Distal Cover recall — Olympus Corporation of the Americas

Hazard: Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

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

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2676-2026
Brand
Olympus of the Americas
Classification
Class II
Units affected
988700 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid

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
UDI/DI: 04953170441271, Lot Numbers: H2530 or later
Distribution
US Nationwide distribution.
Firm notified the public via
Letter
FDA event ID
99106
Recall initiated
June 5, 2026
FDA classified
July 7, 2026
FDA report date
July 15, 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 23, 2026 at 11:04 PM UTC.

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