FDA Recall of 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 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 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, cpsc, Devices.
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 ↗
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 (1,369 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.