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CONNECTING TUBE recallZ-1899-2026 · Olympus Corporation of the Americas · initiated Mar 25, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1899-2026
Status
Open, Classified
Initiated by the company
Mar 25, 2026
Posted by the FDA
Apr 22, 2026
Recalling firm
Olympus Corporation of the Americas
Quantity
10,141 units
Product code
FEB
FDA submissions
K201920
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

Product description

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

Code information (models, lots, serial numbers)

Model Number: MAJ-2111. UDI Number: 04953170404061. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 22A, 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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K201920 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98544).

Sources and updates

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