Reported Oct 6, 2021 · Terminated
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · 18034-0610
Is this the product you have?
BF-3C40 OES BronchofiberscopeModel No. BF-3C40
- Lot codes and dates
- All serial numbers
- Amount recalled
- 484
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
This product could cause temporary or reversible health problems — stop using it.
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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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