CLASS I ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Bronchovideoscope Olympus Bf Type 1t150 recalled
Olympus Corporation of the Americas is recalling Bronchovideoscope Olympus Bf Type 1t150, 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
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-0045-2026
- 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 TYPE 1T150
Where it was distributed
US Nationwide Distribution.
Questions about this recall
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-1T150; UDI: 4953170308185; 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 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
22 other products · FDA event 97441This product is part of a recall event; the main page for the event is Evis Exera Bronchovideoscope Olympus Bf Type Xt160 recalled.
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