OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111

FDA device recall Z-1899-2026 · posted 2026-04-22 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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

Action taken

Olympus notified consignees on about 03/25/2026 via letter titled "URGENT: MEDICAL DEVICE REMOVAL." Consignees were notified of the issue and hazard involved and were instructed to examine inventory and OER-ELITE devices for the affected product. The current version has black lock levers. The previous versions have gray lock levers or integrated lock levers, which are the same color as the rest of the connector. Consignees were instructed that if they have sufficient quantities of the current version (black) to support reprocessing needs, stop using the previous version and set aside for return. They may proceed with using the current version, only. If they have insufficient quantities of the current version (black) available, and do not have another method of endoscope reprocessing readily available, they may continue using the previous version(s) consistent with the Instructions for Use, which require users to inspect the connecting tube prior to use. Transition to the current version as soon as possible by placing an order through Customer Service at 1-800-848-9024, option 2. When sufficient quantities of the current version (black) are obtained to support reprocessing needs, stop using the previous version and only use the current version going forward. Then arrange for return the previous version of the connector. Consignees were also requested to confirm receipt of the letter through the Olympus web portal and forward the notification to other users who may have the affected products if product were further distributed.

Root cause

Device Design

Status

Open, Classified

Product code

FEB

Quantity affected

10,141 units

Distribution

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

Date initiated

2026-03-25

Date posted

2026-04-22

Location

Center Valley, PA

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