FDA recall, , Moderate risk
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes
The OER-ELITE Endoscope Reprocessor Connecting Tubes may have lock levers that fail prematurely.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, recalled OER-ELITE Endoscope Reprocessor Connecting Tubes because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The recall began March 25, 2026, and was added to the FDA's Enforcement Report on April 22, 2026. Distribution was worldwide, including the US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your tube affected?
Match your product and all the details in one listed combination.
A UDI-DI is the device identifier printed with the barcode on the device label.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
- UDI-DI
- 04953170404054
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 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
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/
- UDI-DI
- 04953170404108
- Catalog code
- MAJ-2115.
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 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
- 51A
- UDI-DI
- 04953170404085
- Catalog code
- MAJ-2113.
- Lot code
- 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
- UDI-DI
- 04953170404146
- Catalog code
- MAJ-2119.
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 14A
- 15A
- 16A
- 17A
- 18A
- 1XA
- 1YA
- 1ZA
- 22A
- 23A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
- 33A
- 34A
- 35A
- 36A
- 37A
- 38A
- 3XA
- 3YA
- 3ZA
- 41A
- 42A
- 43A
- 44A
- 45A
- 46A
- 47A
- 48A
- 4XA
- 4YA
- 51A
- UDI-DI
- 04953170404092
- Catalog code
- MAJ-2114.
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 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
- UDI-DI
- 04953170404184
- Catalog code
- MAJ-2138.
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 3XA
- 3YA
- 3ZA
- 41A
- 42A
- 43A
- 44A
- 45A
- 46A
- 47A
- 48A
- 49A
- 4XA
- 4YA
- 4ZA
- 51A
- UDI-DI
- 04953170404139
- Catalog code
- MAJ-2118.
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 23A
- 24A
- 25A
- 26A
- 27A
- 28A
- 2YA
- 34A
- 35A
- 36A
- 37A
- 38A
- 3XA
- 3YA
- 3ZA
- 41A
- 42A
- 43A
- 44A
- 45A
- 46A
- 47A
- 48A
- 49A
- 4XA
- 4YA
- 4ZA
- 51A
- UDI-DI
- 04953170404122
- Catalog code
- MAJ-2117.
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
- 33A
- 34A
- 35A
- 36A
- 37A
- 39A
- 3XA
- 3YA
- 3ZA
- 41A
- 42A
- 43A
- 44A
- 45A
- 46A
- 47A
- 48A
- 49A
- 4YA
- 4ZA
- 51A
- UDI-DI
- 04953170404061
- Catalog code
- MAJ-2111
- Lot code
- 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
- UDI-DI
- 04953170404078
- Catalog code
- MAJ-2112
- Lot code
- 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
- UDI-DI
- 04953170404115
- Catalog code
- MAJ-2116.
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 25A
- 26A
- 27A
- 28A
- 45A
- 46A
- 47A
- 48A
- 49A
- 4XA
- 4YA
- 51A
- UDI-DI
- 04953170404207
- Catalog code
- MAJ-2330.
- Lot code
- 09A
- 0XA
- 0YA
- 0ZA
- 11A
- 12A
- 24A
- 25A
- 26A
- 27A
- 28A
- 29A
- 2XA
- 2YA
- 2ZA
- 31A
- 32A
- 33A
- 34A
- 35A
- 36A
- 38A
- 39A
- 3XA
- 3YA
- 3ZA
- 41A
- 42A
- 43A
- 44A
- 45A
- 46A
- 47A
- 48A
- 49A
- 4XA
- 4YA
- 4ZA
- 51A
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98544
- Recall numbers
- Z-1898-2026 to Z-1909-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
