Recall of Olympus Endoscope Suction Valve MAJ-1443
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 recall 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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/.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,025 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.