Recall of Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes
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 of the Americas is recalling 1,259 units of the OER-ELITE Endoscope Reprocessor Connecting Tubes due to potential premature failure of the lock levers.
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 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.
What Happened
Olympus Corporation of the Americas is recalling the 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 the OER-ELITE Endoscope Reprocessor Connecting Tubes with Model/Catalog Number: MAJ-2118. The UDI Number is 04953170404139, and the Lot Numbers include: 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, and 4ZA. A total of 1,259 units are affected, distributed US Nationwide and in the countries of Canada, China, Hong Kong, Japan, South Korea, and Taiwan.
What You Should Do
Consumers should contact Olympus Corporation of the Americas for further instructions, as the recall was initiated via letter. The firm is located at 3500 Corporate Pkwy, Center Valley, PA 18034-8229. For returns or refunds, reach out to the recalling firm using the provided recall number Z-1906-2026.
Why This Matters
This recall involves medical devices that could impact procedures if the lock levers fail, potentially affecting patient safety in healthcare settings.
Source
FDA recall notice for event ID 98544, available via the FDA website.
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 (1,324 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.