Reported Jul 26, 2023 · Ongoing
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
Olympus Corporation of the Americas
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
- Lot codes and dates
- All serial numbers BF-H190 EVIS EXERA III
- BRONCHOVIDEOSCOPE OLYMPUS BF-H190 UDI04953170434754 BF-Q190 EVIS EXERA III
- BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 UDI04953170335198 BF-XT190 EVIS EXERA III
- BRONCHOVIDEOSCOPE OLYMPUS BF-XT190UDI04953170402470 BF-1TH190 EVIS EXERA III
- BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 UDI04953170434778
- Amount recalled
- 9,684 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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