CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

Bf-XP160F Evis Exera Bronchovideoscope recalled

Olympus Corporation of the Americas is recalling Bf-XP160F Evis Exera Bronchovideoscope, distributed nationwide in the US. The recall was initiated on 16 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled644

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-2569-2021
FDA event ID: 88562
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 16 Aug 2021
FDA classified: 24 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Aug 2021	Recall initiated by company
24 Sep 2021	Classified by FDA	+39 days
6 Oct 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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."

Product as listed by the FDA

BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F

Where it was distributed

Domestic distribution nationwide. Product also distributed globally.

Nationwide

Questions about this recall

Why was it recalled?

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."

Which lots are affected?

All serial numbers

Where was it sold?

Domestic distribution nationwide. Product also distributed globally.

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 21 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

9 other products · FDA event 88562

This product is part of a recall event; the main page for the event is BF-XP60 OES Bronchofiberscope recalled by Olympus Corporation of the.

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021	CLASS II	BF-XP60 OES Bronchofiberscope recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
6 Oct 2021	CLASS II	Bf-1T180 Evis Exera II Bronchovideoscope recalled	Olympus Corporation of the Americas	Other	Nationwide
6 Oct 2021	CLASS II	BF-3C40 OES Bronchofiberscope recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
6 Oct 2021	CLASS II	Bf-XT160 Evis Exera Bronchovideoscope recalled	Olympus Corporation of the Americas	Other	Nationwide
6 Oct 2021	CLASS II	BF-1T60 OES Bronchofiberscope recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
6 Oct 2021	CLASS II	BF-N20 OES Bronchofiberscope recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
6 Oct 2021	CLASS II	BF-P60 OES Bronchofiberscope recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
6 Oct 2021	CLASS II	Bf-Q180-AC Evis Exera II Bronchovideoscope recalled	Olympus Corporation of the Americas	Other	Nationwide
6 Oct 2021	CLASS II	Bf-P180 Evis Exera II Bronchovideoscope recalled	Olympus Corporation of the Americas	Other	Nationwide

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