FDA 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.
The FDA has announced a voluntary recall of 2,089 units of Olympus's OER-ELITE Endoscope Reprocessor Connecting Tubes due to the specified reason.
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.
Recall Article
What Happened
Olympus Corporation of the Americas is recalling the OER-ELITE Endoscope Reprocessor Connecting Tubes due to the reason specified as XXX.
Which Products Are Affected
The affected products are OER-ELITE Endoscope Reprocessor Connecting Tubes with Model/Catalog Number: MAJ-2115 and UDI Number: 04953170404108. The recall involves 2,089 units with 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. These products were distributed nationwide in the United States and in the countries of Canada, China, Hong Kong, Japan, South Korea, and Taiwan.
What You Should Do
Consumers who have the affected products should contact Olympus Corporation of the Americas, as the initial notification was via letter. The firm's address is 3500 Corporate Pkwy, Center Valley, PA 18034-8229.
Why This Matters
This recall involves medical devices and could affect product safety, with the FDA classifying it as Class II, indicating potential for temporary or reversible health consequences that are not likely to be serious.
Source
FDA Recall Number: Z-1903-2026. For more information, refer to 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 (1,293 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.