Food, drugs, devices › Olympus Corporation of the Americas
Device recall: Bronchovideoscope BF-160
FDA enforcement event 80925 is a device recall by Olympus Corporation of the Americas of Center Valley, PA, initiated 8 Aug 2018 and classified Class II, with 30 product records.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 17 May 2022. Initiation: voluntary: firm initiated. Olympus Corporation of the Americas has 141 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Olympus Corporation of the Americas, Center Valley, PA.
Reason for recall
"The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port."
Distribution
"The products were distributed US nationwide and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3283-2018 | Bronchovideoscope BF-160 | 3948 | Class II | Terminated | 10 Oct 2018 |
| Z-3284-2018 | Bronchofiberscope F-1T160 | 3317 | Class II | Terminated | 10 Oct 2018 |
| Z-3285-2018 | Bronchovideoscope BF-1T180 | 5810 | Class II | Terminated | 10 Oct 2018 |
| Z-3286-2018 | Bronchovidescope BF-1T240 | 1605 | Class II | Terminated | 10 Oct 2018 |
| Z-3287-2018 | Bronchovideoscope BF-1T60 | 2803 | Class II | Terminated | 10 Oct 2018 |
| Z-3288-2018 | Bronchovideoscope F-1TQ180 | 1134 | Class II | Terminated | 10 Oct 2018 |
| Z-3289-2018 | Bronchovideoscope BF-240 | 1467 | Class II | Terminated | 10 Oct 2018 |
| Z-3290-2018 | Bronchovideoscope BF-3C160 | 2318 | Class II | Terminated | 10 Oct 2018 |
| Z-3291-2018 | Bronchovideoscope BF-3C40 | 2479 | Class II | Terminated | 10 Oct 2018 |
| Z-3292-2018 | Bronchofiberscope BF-40 | 1347 | Class II | Terminated | 10 Oct 2018 |
| Z-3293-2018 | Bronchofibercope BF-6C240 | 197 | Class II | Terminated | 10 Oct 2018 |
| Z-3294-2018 | Bronchovideoscope BF-MP160F | 672 | Class II | Terminated | 10 Oct 2018 |
| Z-3295-2018 | Bronchovideoscope BF-MP60 | 653 | Class II | Terminated | 10 Oct 2018 |
| Z-3296-2018 | Bronchovideoscope BF-P160 | 1874 | Class II | Terminated | 10 Oct 2018 |
| Z-3297-2018 | Bronchovideoscope BF-P180 | 3705 | Class II | Terminated | 10 Oct 2018 |
| Z-3298-2018 | Bronchovideoscope BF-P240 | 2163 | Class II | Terminated | 10 Oct 2018 |
| Z-3299-2018 | Bronchofiberscope BF-P40 | 5607 | Class II | Terminated | 10 Oct 2018 |
| Z-3300-2018 | Bronchofiberscope BF-P60 | 5545 | Class II | Terminated | 10 Oct 2018 |
| Z-3301-2018 | Bronchovideoscope BF-Q180 | 5845 | Class II | Terminated | 10 Oct 2018 |
| Z-3302-2018 | Bronchovideoscope BF-Q180-AC | 655 | Class II | Terminated | 10 Oct 2018 |
| Z-3303-2018 | Ultrasonic Bronchoscope BF-UC160F-OL8 | 879 | Class II | Terminated | 10 Oct 2018 |
| Z-3304-2018 | Ultrasonic Bronchoscope BF-UC180F | 4785 | Class II | Terminated | 10 Oct 2018 |
| Z-3305-2018 | Bronchovideoscope BF-XP160F | 1461 | Class II | Terminated | 10 Oct 2018 |
| Z-3306-2018 | Bronchofiberscope BF-XP40 | 817 | Class II | Terminated | 10 Oct 2018 |
| Z-3307-2018 | Bronchofiberscope BF-XP60 | 1296 | Class II | Terminated | 10 Oct 2018 |
| Z-3308-2018 | Bronchovideoscope BF-XT160 | 861 | Class II | Terminated | 10 Oct 2018 |
| Z-3309-2018 | Bronchofiberscope BF-XT40 | 931 | Class II | Terminated | 10 Oct 2018 |
| Z-3310-2018 | Rhino Laryngo scope ENF-VT2 | 3701 | Class II | Terminated | 10 Oct 2018 |
| Z-3311-2018 | Airway Mobilescope MAF-TM | 3456 | Class II | Terminated | 10 Oct 2018 |
| Z-3312-2018 | Bronchovideoscope BF-1T40 | 3,041 | Class II | Terminated | 10 Oct 2018 |
Context
Other enforcement events for Olympus Corporation of the Americas
All 141 events for Olympus Corporation of the Americas
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "The products were distributed US nationwide and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 May 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.