CLASS I ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Evis Exera Ii Bronchovideoscope Olympus Bf Type Q180 recalled

Olympus Corporation of the Americas is recalling Evis Exera Ii Bronchovideoscope Olympus Bf Type Q180, distributed nationwide in the US. The recall was initiated on 11 Sep 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel No. BF-Q180; UDI: 4953170339301; All Serial No.

Quantity recalled665 units US; 2,250 units OUS

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-0061-2026
FDA event ID: 97441
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class I
Status: Ongoing
Recall initiated: 11 Sep 2025
FDA classified: 16 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Sep 2025	Recall initiated by company
16 Oct 2025	Classified by FDA	+35 days
22 Oct 2025	Published in enforcement report	+6 days

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

Reason for recall

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Product as listed by the FDA

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Is Evis Exera Ii Bronchovideoscope Olympus Bf Type Q180 recalled?

Yes. Olympus Corporation of the Americas recalled Evis Exera Ii Bronchovideoscope Olympus Bf Type Q180 on 11 Sep 2025. The recall is Class I and its status is Ongoing. Recall number Z-0061-2026.

Why was it recalled?

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

Which lots are affected?

Model No. BF-Q180; UDI: 4953170339301; All Serial No.

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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.

More recalls from Olympus Corporation of the Americas

All 415

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Foreign Material	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide