Lower risk Medical device recall · FDA · Published August 16, 2021

Olympus BF-XP60 Bronchofiberscope Recall: Updated Reprocessing Instructions

Olympus recalls BF-XP60 OES Bronchofiberscope with updated reprocessing instructions per FDA 2015 guidance. No immediate action needed for safety.

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

🇺🇸 FDA recall #Z-2566-2021Medical device Olympus ›

Lower-risk recall

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

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 BF-XP60 OES Bronchofiberscope due to updated reprocessing instructions following FDA guidance. This does not pose an immediate safety risk to users. Read more at govinfonow.com/recall/61932-olympus-bf-xp60-bronchofiberscope-recall-updated-reprocessing-instructions.

Source Summary by GovInfoNow · govinfonow.com/recall/61932-olympus-bf-xp60-bronchofiberscope-recall-updated-reprocessing-instructions · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2566-2021

Cite this page

“Olympus BF-XP60 Bronchofiberscope Recall: Updated Reprocessing Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61932-olympus-bf-xp60-bronchofiberscope-recall-updated-reprocessing-instructions. Based on FDA recall #Z-2566-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2566-2021%22&limit=1).

Olympus Corporation of the Americas recalled BF-XP60 OES Bronchofiberscopes on Aug. 16, 2021, according to the FDA. The company issued new reprocessing instructions for all serial numbers of the 180 units distributed nationwide and globally.

How to tell if you have it

Brand: Olympus
Product: BF-XP60 OES Bronchofiberscope
Model No.: BF-XP60
Serial numbers: All
Quantity: 180

The hazard

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls of similar products include Olympus Tripp-Lite P580-025 DisplayPort Cable May Cause Video Dropout During Use (2026-08-27), Olympus M3 Gold Autoclavable Foroblique Telescope 30: Sterilization Parameter Discrepancy (2026-08-24), and Olympus Corporation of the Americas recalls Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector (2026-08-19). Other recent recalls of similar products include Olympus OER-Pro Recall: Safety Warnings and Maintenance Cautions (2025-10-31), Olympus OER-Elite Recall: Safety Warnings and Maintenance Cautions (2025-10-31), and Medline Recalls Bronchoscopic Kits with Olympus Biopsy Valves Due to Rubber Fragment Detachment Risk (2026-02-16).

How to tell if you have this one

Check for the model number BF-XP60 on the device. All units with this model are affected, regardless of serial number.

Brand
Olympus
Category
Medical device

FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Domestic distribution nationwide. Product also distributed globally.

Recall number	Product, codes & lots	Quantity
Z-2564-2021	BF-N20 OES Bronchofiberscope, Model No. BF-N20; All serial numbers	377
Z-2565-2021	BF-3C40 OES Bronchofiberscope, Model No. BF-3C40; All serial numbers	484
Z-2566-2021	BF-XP60 OES Bronchofiberscope, Model No. BF-XP60; All serial numbers	180
Z-2567-2021	BF-1T60 OES Bronchofiberscope, Model No. BF-1T60; All serial numbers	350
Z-2568-2021	BF-P60 OES Bronchofiberscope, Model No. BF-P60; All serial numbers	1030
Z-2569-2021	BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F; All serial numbers	644
Z-2570-2021	BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160; All serial numbers	293
Z-2571-2021	BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180; All serial numbers	1177
Z-2572-2021	BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180; All serial numbers	1694
Z-2573-2021	BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC; All serial numbers	431

Based on the official FDA remedy

What to do — step by step

Review Reprocessing Instructions
Follow the updated reprocessing instructions provided by Olympus to ensure safe use.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Domestic distribution nationwide. Product also distributed globally.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Aug 16, 2021Firm started the recall
Sep 24, 2021FDA classified it Class II
Oct 6, 2021Published in FDA’s Enforcement Report
Mar 11, 2024FDA terminated the recall

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/61932-olympus-bf-xp60-bronchofiberscope-recall-updated-reprocessing-instructions">Olympus BF-XP60 Bronchofiberscope Recall: Updated Reprocessing Instructions (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-2566-2021 (August 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2566-2021 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.