CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report
Oer-elite Endoscope Reprocessor Connecting Tubes recalled
Olympus Corporation of the Americas is recalling Oer-elite Endoscope Reprocessor Connecting Tubes, distributed nationwide in the US. The recall was initiated on 25 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1904-2026
- FDA event ID
- 98544
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Mar 2026
- FDA classified
- 22 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 25 Mar 2026 | Recall initiated by company | |
| 22 Apr 2026 | Classified by FDA | +28 days |
| 29 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product as listed by the FDA
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
Questions about this recall
Why was it recalled?
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Which lots are affected?
Model: MAJ-2116. UDI Number: 04953170404115. Lot Numbers: 09A, 0XA, 0YA, 0ZA, 11A, 25A, 26A, 27A, 28A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 98544This product is part of a recall event; the main page for the event is Oer-elite Endoscope Reprocessor Connecting Tubes recalled.
More recalls from Olympus Corporation of the Americas
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|---|---|---|---|---|---|
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| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
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| Device | CLASS II | Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled | ASP Global | Device Malfunction | Nationwide |