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Unrated Medical device recall · FDA · Published March 25, 2026

Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall: Safety Hazard

Olympus recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to potential safety hazard. Affected units include specific lot numbers and UDI numbers. Consumers should contact Olympus for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1903-2026Medical deviceOlympus ›
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Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer

Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes with model number MAJ-2115. The recall is due to a potential safety hazard that could cause injury if the tubes are used improperly. Read more at govinfonow.com/recall/49597-olympus-oer-elite-endoscope-reprocessor-connecting-tubes-recall-safety-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/49597-olympus-oer-elite-endoscope-reprocessor-connecting-tubes-recall-safety-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1903-2026

Cite this page

“Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall: Safety Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49597-olympus-oer-elite-endoscope-reprocessor-connecting-tubes-recall-safety-hazard. Based on FDA recall #Z-1903-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1903-2026%22&limit=1).

The FDA announced on March 25, 2026, that Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes due to an unspecified hazard. The recall affects 2,089 units distributed worldwide.

How to tell if you have it

  • Brand: Olympus
  • Product: OER-ELITE Endoscope Reprocessor Connecting Tubes
  • Model/Catalog Number: MAJ-2115
  • Lot Numbers: 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

The hazard

The official record lists the hazard as XXX. No specific incidents or injuries are reported in the provided facts.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since August 18, 2017. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (August 27, 2026), the Olympus M3 Gold Autoclavable Foroblique Telescope (August 24, 2026), and the Olympus BiCOAG Hemostasis Probe (August 19, 2026). Similar product recalls include the Olympus OER-Elite Recall on October 31, 2025, the Olympus OER-Pro Recall on October 31, 2025, and the Medtronic Octopus Nuvo Tissue Stabilizer Recall on January 13, 2026.

How to tell if you have this one

Check for the model number MAJ-2115 on the connecting tubes. Look for the specific lot numbers listed: 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.

  • Brand
    Olympus
  • Category
    Medical device
FDA recall event · 12 products

All 12 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Recall numberProduct, codes & lotsQuantity
Z-1898-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.; Model Number: MAJ-2110. UDI Number: 04953170404054. Lot Numbers: 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.9,757 units
Z-1899-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111; 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.10,141 units
Z-1900-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112; 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.8,994 units
Z-1901-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.; Model Number: MAJ-2113. UDI Number: 04953170404085. 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.8,936 units
Z-1902-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.; Model Number: MAJ-2114. UDI Number: 04953170404092. Lot Numbers: 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.2,143 units
Z-1903-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.; Model Number: MAJ-2115. UDI Number: 04953170404108. Lot Numbers: 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.2,089 units
Z-1904-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.; Model: MAJ-2116. UDI Number: 04953170404115. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 25A, 26A, 27A, 28A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A.373 units
Z-1905-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.; Model Number: MAJ-2117. UDI Number: 04953170404122. Lot Numbers: 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.1,929 units
Z-1906-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.; Model Number: MAJ-2118. UDI Number: 04953170404139. Lot Numbers: 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.1,259 units
Z-1907-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.; Model Number: MAJ-2119. UDI Number: 04953170404146. Lot Numbers: 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.741 units
Z-1908-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.; Model Number: MAJ-2138. UDI Number: 04953170404184. Lot Numbers: 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.808 units
Z-1909-2026OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.; Model Number: MAJ-2330. UDI Number: 04953170404207. Lot Numbers: 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.1,829 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the model number (MAJ-2115) and lot numbers on the connecting tubes to confirm if your item is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Mar 25, 202612. FDA classified it Class II: Apr 22, 202623. Published in FDA’s Enforcement Report: Apr 29, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1903-2026 (March 25, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1903-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA