Olympus Corporation of the Americas 2022-05-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1047-2022
BF-3C160: EVIS EXERA Bronchovideoscope Recall
Issued May 18, 2022 · Olympus Corporation of the Americas
In May 2022, Olympus Corporation of the Americas recalled the BF-3C160: EVIS EXERA Bronchovideoscope, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using BF-3C160: EVIS EXERA Bronchovideoscope right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Olympus Corporation of the Americas to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Olympus Corporation of the Americas
- Category
- Health
- Recall date
- May 18, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-1047-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.