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WarningRecall #Z-1901-2026Medical Device

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

Olympus Corporation of the Americas · Class II — Moderate Risk

Hospital operating room medical equipment — representative photo for FDA medical device recall
A hospital operating room with medical equipment (representative file photo). Specific recalled device: see recall details below. Photo: FDA / Public Domain.

Product Description

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.

Reason for Recall

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

FDA Classification

Class II — Moderate Risk

A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

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