The Recall Desk

FDA (Devices) recall action 93052

Olympus Corporation of the Americas recalled 6 products on 2023-11-15

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2023-11-15
Critical
0
Units
67,924

Why these products were recalled

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • SevereFDA (Devices)··2023-11-15

    Five Olympus Bronchovideoscope Models Recalled for Endobronchial Combustion Risk

    Olympus is recalling 15,942 bronchovideoscope units nationwide due to endobronchial combustion risk during cauterization procedures with oxygen supply. The hazard occurs when the electrode of the surgical accessory is positioned too close to the scope's distal end.

    Product
    BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2023-11-15

    Olympus Bronchovideoscope Recalled for Fire Risk During Cauterization

    Olympus Corporation recalls 13,950 EVIS EXERA II bronchovideoscopes due to risk of endobronchial combustion when high-frequency cauterization is performed with oxygen supplied while the electrode is positioned too close to the endoscope.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2023-11-15

    Olympus Bronchovideoscope Recalled Due to Combustion Risk

    Olympus is recalling 719 EVIS EXERA b Bronchovideoscope Model BF-XT190 devices due to risk of endobronchial combustion during high-frequency cauterization when oxygen is supplied or the electrode is too close to the device tip.

    Product
    EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2023-11-15

    FDA Recalls Olympus EVIS EXERA III Bronchovideoscope for Combustion Risk

    Olympus Corporation is recalling 3,948 EVIS EXERA III bronchovideoscope units nationwide due to risk of combustion during electrosurgical procedures when high-frequency cauterization is used with oxygen supply.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2023-11-15

    Olympus Bronchovideoscopes Recalled for Endobronchial Combustion Risk

    Olympus is recalling bronchovideoscopes nationwide due to a risk of combustion inside the bronchial passages during high-frequency cauterization if oxygen is supplied or the electrode is positioned too close to the scope's tip.

    Product
    EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2023-11-15

    Olympus Bronchovideoscope Recall for Combustion Risk with Electrosurgery

    Olympus is recalling 1,154 EVIS EXERA II bronchovideoscope units due to risk of endobronchial combustion during high-frequency electrosurgical procedures when oxygen is supplied and electrode placement is inappropriate.

    Product
    EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
    Category
    Distribution
    0 states