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

Bronchovideoscope Olympus Bf-1th1100 recalled

Olympus Corporation of the Americas is recalling Bronchovideoscope Olympus Bf-1th1100, 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-1TH1100; UDI: 4953170424199; All Serial No.

Quantity recalled0 units US; 1,913 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-0048-2026
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

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Is Bronchovideoscope Olympus Bf-1th1100 recalled?

Yes. Olympus Corporation of the Americas recalled Bronchovideoscope Olympus Bf-1th1100 on 11 Sep 2025. The recall is Class I and its status is Ongoing. Recall number Z-0048-2026.

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-1TH1100; UDI: 4953170424199; 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.

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