Recall of Olympus Endoscope Suction Valve MAJ-1443

FDA Recalls medium FDA · · United States

Olympus Corporation is recalling 47,383 units of their Endoscope Suction Valve due to incompatibility with specific automated endoscope reprocessors, affecting nationwide distribution in the US.

What this fda recalls alert tells you, and what most readers miss

This notice was issued by FDA on April 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 an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert 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 alerts 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 recalls advisory 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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Recall Article

What Happened

The recall is due to the Olympus Endoscope Suction Valve MAJ-1443 no longer being compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

Which Products Are Affected

The affected product is Olympus Endoscope Suction Valve, Model Number: MAJ-1443, UDI-DI: 04953170355912, and Catalog Number: N5363430. All Lot/Serial Numbers are included, with a total of 47,383 units distributed US Nationwide.

What You Should Do

Consumers should contact the recalling firm, Olympus Corporation of the Americas, at their address 3500 Corporate Pkwy, Center Valley, PA 18034-8229, for instructions, as the recall was initiated via letter.

Why This Matters

This recall involves medical devices that could affect proper reprocessing in healthcare settings, potentially impacting patient safety due to the incompatibility issue.

Source

FDA Recall Number: Z-1610-2026. For more information, visit the FDA website at https://www.fda.gov/medical-devices/medical-device-recalls/.

Source: FDA Official Notice

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Frequently Asked Questions

What is this fda recalls alert about?
Olympus Corporation is recalling 47,383 units of their Endoscope Suction Valve due to incompatibility with specific automated endoscope reprocessors, affecting nationwide distribution in the US.
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 alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.