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.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0045-2026 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 | 3 units US; 1,987 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0046-2026 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 | 1,473 units US; 3,774 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0047-2026 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 | 347 units US; 2,869 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0048-2026 | BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 | 0 units US; 1,913 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0049-2026 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 | 4,297 units US; 4,290 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0050-2026 | BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 | 0 units US; 2,092 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0051-2026 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 | 215 units US; 736 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0052-2026 | BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 | 0 units US; 1,867 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0053-2026 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 | 5,221 units US; 4,321 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0054-2026 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 | 59 units US; 665 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0055-2026 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 | 0 units US; 1,019 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0056-2026 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 | 1,070 units US; 2,180 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0057-2026 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 | 3,046 units US; 2,414 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0058-2026 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 | 1,007 units US; 5,443 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0059-2026 | BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 | 2 units US; 4,289 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0060-2026 | BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 | 1 unit US; 2,306 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0061-2026 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 | 665 units US; 2,250 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0062-2026 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC | 395 units US; 165 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0063-2026 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 | 916 units US; 1,402 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0064-2026 | BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 | 1 unit US; 5,286 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0065-2026 | EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 | 262 units US; 558 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0066-2026 | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 | 361 units US; 258 units OUS | Class I | Ongoing | 22 Oct 2025 |
| Z-0067-2026 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 | 116 units US; 705 units OUS | Class I | Ongoing | 22 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
- FDA enforcement report Z-0045-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
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.