Lower risk Medical device recall · FDA · Published August 17, 2021

Olympus EVIS EXERA BF-XT160 Bronchofibervideoscope Recall: Infection Risk from Tube Leak

Olympus recalls EVIS EXERA BF-XT160 bronchoscopy scopes due to potential insertion tube leaks causing infection control risks. Affected units sold in the U.S. from 2019 to 2023.

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

🇺🇸 FDA recall #Z-2497-2021Medical device Olympus ›

Lower-risk recall

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

Take action

Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, PO Box 610 · Center Valley, PA 18034-0610

✎ GovInfoNow plain-language explainer

Olympus is recalling its EVIS EXERA BF-XT160 bronchoscopy scopes because a manufacturing step was skipped, which could cause the insertion tube to leak and create infection risks. This affects medical devices used during procedures like bronchoscopy. Read more at govinfonow.com/recall/61931-olympus-evis-exera-bf-xt160-bronchofibervideoscope-recall-infection-risk-from.

Source Summary by GovInfoNow · govinfonow.com/recall/61931-olympus-evis-exera-bf-xt160-bronchofibervideoscope-recall-infection-risk-from · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2497-2021

Cite this page

“Olympus EVIS EXERA BF-XT160 Bronchofibervideoscope Recall: Infection Risk from Tube Leak.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61931-olympus-evis-exera-bf-xt160-bronchofibervideoscope-recall-infection-risk-from. Based on FDA recall #Z-2497-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2497-2021%22&limit=1).

The FDA announced on Aug. 17, 2021, that Olympus Corporation of the Americas is recalling the EVIS EXERA BF-XT160 Bronchofibervideoscope due to a potential leak in the insertion tube. This manufacturing defect poses an infection control risk.

How to tell if you have it

Brand: Olympus
Product: EVIS EXERA BF-XT160 Bronchofibervideoscope
Model No.: BF-XT160
Lot codes: 1200148, 2500873, 2100707, 2710983, 1500300, 1400209, 2600505, 1300163, 1400273, 1400248, 2700521, 2500431, 1500310, 1200129, 2300805, 2811029, 1500292, 2700520, 2100743, 1500313, 2911060
Distribution: US Nationwide in CA, IL, MA, MD, MI, NY, OH, OR, and PA

The hazard

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since Aug. 18, 2017. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (Aug. 27, 2026), the Olympus M3 Gold Autoclavable Foroblique Telescope 30: (Aug. 24, 2026), and the Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector (Aug. 19, 2026). Other recent recalls of similar products include Medline Recalls Bronchoscopic Kits with Olympus Biopsy Valves Due to Rubber Fragment Detachment Risk (Feb. 16, 2026), Medline Recalls Olympus Biopsy Kits: Risk of Foreign Body in Patient Airway (Feb. 16, 2026), and Medline Recalls Olympus Biopsy Valves Due to Risk of Foreign Body in Airway (Feb. 16, 2026).

How to tell if you have this one

Check for the model number BF-XT160 on the device. The product was sold in the U.S. between 2019 and 2023.

Brand
Olympus
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number BF-XT160 on the device to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

FDA distribution: “US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Illinois, Maryland, Massachusetts, Michigan, New York, Ohio, Oregon, Pennsylvania.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Aug 17, 2021Firm started the recall
Sep 21, 2021FDA classified it Class II
Sep 29, 2021Published in FDA’s Enforcement Report
Jan 12, 2024FDA terminated the recall

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

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61931-olympus-evis-exera-bf-xt160-bronchofibervideoscope-recall-infection-risk-from">Olympus EVIS EXERA BF-XT160 Bronchofibervideoscope Recall: Infection Risk from Tube Leak (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-2497-2021 (August 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2497-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.