Device recall: Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Class II FDA enforcement event 92779. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Olympus Corporation of the Americas started this device recall on 27 Jul 2023. The firm address in the FDA record is in Center Valley, PA. FDA put the recall in Class II. FDA event 92779 has 15 product records. The first FDA enforcement report date is 6 Sep 2023. 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
15 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2490-2023 | Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160. | 1715 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2491-2023 | Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60. | 1072 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2492-2023 | Olympus Bronchovideoscope, Model BF-Q180-AC | 416 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2493-2023 | Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180. | 3652 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2494-2023 | Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F. | 4115 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2495-2023 | Olympus Airway Mobilescope, Models MAF-GM & MAF-TM. | 1859 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2496-2023 | Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190. | 9449 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2497-2023 | Olympus Bronchovideoscope, Models BF-MP190F. | 441 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2498-2023 | Olympus Bronchovideoscope, Models BF-XT190. | 235 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2499-2023 | Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2. | 122 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2500-2023 | Olympus Bronchovideoscope, Models BF-P190 & BF-XP190. | 3949 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2501-2023 | Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V. | 2127 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2502-2023 | Olympus Bronchovideoscope, Models BF-3C40 & BF-N20. | 881 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2503-2023 | Olympus Bronchovideoscope, Models BF-3C160. | 1004 units | Class II | Ongoing | 6 Sep 2023 |
| Z-2504-2023 | Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP. | 10801 units | Class II | Ongoing | 6 Sep 2023 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 15Median of the firm: 1
- Events of the firm on the register
- 141
Other events of the firm
Official channels
- FDA enforcement report Z-2490-2023The 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 92779. https://recallregister.com/fda/ii/92779/. 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 92779?
- The event has 15 product records. The first record gives this quantity:
1715 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.