FDA Recall of OER-ELITE Endoscope Reprocessor Connecting Tubes

Source: FDA · United States

Olympus Corporation of the Americas is recalling 741 units of OER-ELITE Endoscope Reprocessor Connecting Tubes due to potential failure of lock levers, affecting devices distributed nationwide in the US and internationally.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Olympus Corporation of the Americas is recalling certain OER-ELITE Endoscope Reprocessor Connecting Tubes because of a potential for the Version 2 reprocessor connecting tube lock levers to fail prematurely.

Which Products Are Affected

The affected products are OER-ELITE Endoscope Reprocessor Connecting Tubes with Model/Catalog Number: MAJ-2119. The UDI Number is 04953170404146, and the Lot Numbers include: 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. A total of 741 units are affected, with distribution in the United States nationwide and in the countries of Canada, China, Hong Kong, Japan, South Korea, and Taiwan. The official recall number is Z-1907-2026.

What You Should Do

Consumers should contact the recalling firm, Olympus Corporation of the Americas, as the recall was initiated via letter, for instructions on how to proceed with returns or refunds.

Why This Matters

This recall involves medical devices that could malfunction, potentially leading to temporary health consequences, highlighting the importance of ensuring device reliability in healthcare settings.

Source

This recall information is from the FDA, recall number Z-1907-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Olympus Corporation of the Americas is recalling 741 units of OER-ELITE Endoscope Reprocessor Connecting Tubes due to potential failure of lock levers, affecting devices distributed nationwide in the US and internationally.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.