CLASS II ONGOING Device recall · Reported 18 May 2022 · FDA Enforcement Report

Bf-1TQ180: Evis Exera II Bronchovideoscope recalled

Olympus Corporation of the Americas is recalling Bf-1TQ180: Evis Exera II Bronchovideoscope, distributed nationwide in the US. The recall was initiated on 8 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers. UDI: 04953170339349

Quantity recalled242 units

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-1049-2022
FDA event ID: 89942
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Mar 2022
FDA classified: 6 May 2022
Reported: 18 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

8 Mar 2022	Recall initiated by company
6 May 2022	Classified by FDA	+59 days
18 May 2022	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

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

BF-1TQ180: EVIS EXERA II Bronchovideoscope

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All serial numbers. UDI: 04953170339349

Where was it sold?

US Nationwide distribution.

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 26 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

3 other products · FDA event 89942

This product is part of a recall event; the main page for the event is Bf-3C160: Evis Exera Bronchovideoscope recalled.

Reported	Class	Recall	Company	Reason	Where
18 May 2022	CLASS II	Bf-3C160: Evis Exera Bronchovideoscope recalled	Olympus Corporation of the Americas	Sterility	Nationwide
18 May 2022	CLASS II	Bf-MP160F: Evis Exera Bronchofibervideoscope recalled	Olympus Corporation of the Americas	Sterility	Nationwide
18 May 2022	CLASS II	BF-MP60: OES Bronchofiberscope recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Sterility	Nationwide

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