Recall Register

Device recall: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

Class I FDA enforcement event 97441. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Olympus Corporation of the Americas started this device recall on 11 Sep 2025. The firm address in the FDA record is in Center Valley, PA. FDA put the recall in Class I. FDA event 97441 has 23 product records. The first FDA enforcement report date is 22 Oct 2025. The record gives the status Ongoing.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

US Nationwide Distribution.

Recalling firm

Olympus Corporation of the Americas, Center Valley, PA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

23 product records in the event.

FDA event 97441: product records
Recall numberProductQuantityClassStatusReport date
Z-0045-2026BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T1503 units US; 1,987 units OUSClass IOngoing22 Oct 2025
Z-0046-2026EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T1801,473 units US; 3,774 units OUSClass IOngoing22 Oct 2025
Z-0047-2026OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60347 units US; 2,869 units OUSClass IOngoing22 Oct 2025
Z-0048-2026BRONCHOVIDEOSCOPE OLYMPUS BF-1TH11000 units US; 1,913 units OUSClass IOngoing22 Oct 2025
Z-0049-2026EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1904,297 units US; 4,290 units OUSClass IOngoing22 Oct 2025
Z-0050-2026BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ1700 units US; 2,092 units OUSClass IOngoing22 Oct 2025
Z-0051-2026EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180215 units US; 736 units OUSClass IOngoing22 Oct 2025
Z-0052-2026BRONCHOVIDEOSCOPE OLYMPUS BF-H11000 units US; 1,867 units OUSClass IOngoing22 Oct 2025
Z-0053-2026EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H1905,221 units US; 4,321 units OUSClass IOngoing22 Oct 2025
Z-0054-2026OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP6059 units US; 665 units OUSClass IOngoing22 Oct 2025
Z-0055-2026BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P1500 units US; 1,019 units OUSClass IOngoing22 Oct 2025
Z-0056-2026EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P1801,070 units US; 2,180 units OUSClass IOngoing22 Oct 2025
Z-0057-2026EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P1903,046 units US; 2,414 units OUSClass IOngoing22 Oct 2025
Z-0058-2026OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P601,007 units US; 5,443 units OUSClass IOngoing22 Oct 2025
Z-0059-2026BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE22 units US; 4,289 units OUSClass IOngoing22 Oct 2025
Z-0060-2026BRONCHOVIDEOSCOPE OLYMPUS BF-Q1701 unit US; 2,306 units OUSClass IOngoing22 Oct 2025
Z-0061-2026EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180665 units US; 2,250 units OUSClass IOngoing22 Oct 2025
Z-0062-2026EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC395 units US; 165 units OUSClass IOngoing22 Oct 2025
Z-0063-2026EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190916 units US; 1,402 units OUSClass IOngoing22 Oct 2025
Z-0064-2026BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE21 unit US; 5,286 units OUSClass IOngoing22 Oct 2025
Z-0065-2026EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160262 units US; 558 units OUSClass IOngoing22 Oct 2025
Z-0066-2026EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190361 units US; 258 units OUSClass IOngoing22 Oct 2025
Z-0067-2026OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40116 units US; 705 units OUSClass IOngoing22 Oct 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2025
945
Share of these events in Class I
13%
Product records in this event
23Median of the firm: 1
Events of the firm on the register
141

Other events of the firm

Official channels

Cite this page

Recall Register. FDA enforcement event 97441. https://recallregister.com/fda/i/97441/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: US Nationwide Distribution.
What quantity of product is in FDA event 97441?
The event has 23 product records. The first record gives this quantity: 3 units US; 1,987 units OUS
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?
13% of the 945 device events that started in 2025 are in Class I.