FDA recall record

Olympus Corporation of the Americas OER-ELITE Endoscope Reprocessor Connecting Tubes recall — FDA Z-1898-2026

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

Class IIclassification
Z-1898-2026official record ID
Apr 29, 2026report date

Recall record at a glance

Official recordZ-1898-2026
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmOlympus Corporation of the Americas
Report dateApr 29, 2026
Recall initiation dateMar 25, 2026
Quantity9,757 units
LocationCenter Valley, PA, United States

Official product description

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

Why the product was recalled

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

Distribution information

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

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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