Reported May 18, 2022 · Ongoing
BF-3C160: EVIS EXERA Bronchovideoscope
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 · 18034-8229
Is this the product you have?
- BF-3C160EVIS EXERA Bronchovideoscope
- Lot codes and dates
- All serial numbers
- UDI04953170340031
- Amount recalled
- 1052 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
This product could cause temporary or reversible health problems — stop using it.
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