FDAClass IIApril 29, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes recall

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112

Why was OER-ELITE Endoscope Reprocessor Connecting Tubes recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: MAJ-2112. UDI Number: 04953170404078. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 12A, 21A, 22A, 23A, 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.

Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Recalling firm
Olympus Corporation of the Americas
Quantity
8,994 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Recall date
April 29, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls