Lower risk Medical device recall · FDA · Published October 14, 2025

Olympus EVIS EXERA III Duodenoscope Recall: Infection Risk from Improper Reprocessing

Olympus recalls EVIS EXERA III duodenoscopes (model TJF-Q190V) due to infection risks from improper reprocessing. Users must follow updated cleaning instructions to prevent infections.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0579-2026Medical device Olympus ›

Lower-risk recall

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

Take action

Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

✎ GovInfoNow plain-language explainer

Olympus is recalling its EVIS EXERA III duodenoscopes (model TJF-Q190V) because improper reprocessing can lead to infections. Following updated cleaning instructions is critical to prevent health risks. Read more at govinfonow.com/recall/51058-olympus-evis-exera-iii-duodenoscope-recall-infection-risk-from-improper.

Source Summary by GovInfoNow · govinfonow.com/recall/51058-olympus-evis-exera-iii-duodenoscope-recall-infection-risk-from-improper · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0579-2026

Cite this page

“Olympus EVIS EXERA III Duodenoscope Recall: Infection Risk from Improper Reprocessing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51058-olympus-evis-exera-iii-duodenoscope-recall-infection-risk-from-improper. Based on FDA recall #Z-0579-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0579-2026%22&limit=1).

The FDA announced on Oct. 14, 2025, that Olympus Corporation of the Americas is recalling the Olympus TJF-Q190V duodenovideoscope due to infection risks from reprocessing deviations. The agency said users must follow updated instructions and use provided materials.

How to tell if you have it

Brand: EVIS EXERA III Duodenovideoscope
Product Name: Olympus TJF-Q190V
Model/Catalog Number: TJF-Q190V
UDI: 04953170405563 / 04953170452024
Serial Numbers: All

The hazard

The FDA said continued reports of positive cultures and infections have identified updates to reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls include an Olympus Tripp-Lite P580-025 cable (2026-08-27), an Olympus M3 Gold Autoclavable Lateral Telescope (2026-08-24), and an Olympus BiCOAG Hemostasis Probe (2026-08-19). Other recent recalls of similar products include an Olympus OER-Pro recall (2025-10-31) and Medline recalls of Olympus biopsy valves and kits (2026-02-16).

How to tell if you have this one

Check for the model number TJF-Q190V on the duodenoscope. These scopes were sold with serial numbers starting with the UDI codes 04953170405563 or 04953170452024.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Review Reprocessing Instructions
Follow updated cleaning and reprocessing guidelines provided by Olympus to minimize infection risks.

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 50 days after the firm started it.

Oct 14, 2025Firm started the recall
Nov 21, 2025FDA classified it Class II
Dec 3, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51058-olympus-evis-exera-iii-duodenoscope-recall-infection-risk-from-improper">Olympus EVIS EXERA III Duodenoscope Recall: Infection Risk from Improper Reprocessing (GovInfoNow)</a>

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-0579-2026 (October 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0579-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.