Olymp: Single Use Distal Cover Recall - Safety Update for Duodenovideoscopes
Olympus recalls single-use distal covers (MAJ-2315) for EVIS EXERA III duodenovideoscopes due to new design release. Affected units include specific lot numbers and UDI codes.
Lower-risk recall
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Contact the company
What happened, in plain English
Olympus is recalling single-use distal covers (MAJ-2315) that come with EVIS EXERA III duodenovideoscopes. This recall is because Olympus has released a new design to replace the previous version. Read more at govinfonow.com/recall/49037-olymp-single-use-distal-cover-recall-safety-update-for-duodenovideoscopes.
Source Summary by GovInfoNow · govinfonow.com/recall/49037-olymp-single-use-distal-cover-recall-safety-update-for-duodenovideoscopes · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2676-2026
Cite this page
“Olymp: Single Use Distal Cover Recall - Safety Update for Duodenovideoscopes.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49037-olymp-single-use-distal-cover-recall-safety-update-for-duodenovideoscopes. Based on FDA recall #Z-2676-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2676-2026%22&limit=1).
Why it’s dangerous
The recall involves a design update from Olympus to replace older distal covers. The hazard is not described as causing injury in normal use, so the risk is low.
Who’s affected
Medical professionals using Olympus EVIS EXERA III duodenovideoscopes with the specific distal cover model (MAJ-2315) are affected. Patients using these scopes under medical supervision are at minimal risk.
How to tell if you have this one
Check for the catalog number MAJ-2315 on the distal cover. The product is used with EVIS EXERA III duodenovideoscopes (model TJF-Q190V-). Lot numbers H2530 or later are affected.
- Brand
Olympus- Category
Medical device
What to do — step by step
Check Product Details
Look for the catalog number MAJ-2315 on the distal cover and verify it's used with EVIS EXERA III duodenovideoscopes (model TJF-Q190V-).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
The recall does not require immediate action; check the product details to see if it's affected.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2676-2026 (June 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2676-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.