Olympus Corporation of the Americas 2023-11-15 Health serious FDA
Health · FDA · Recall #FDA-Z-0288-2024
EVIS EXERA III Gastrointestinal Videoscope Recall
Issued November 15, 2023 · Olympus Corporation of the Americas
In November 2023, Olympus Corporation of the Americas recalled the EVIS EXERA III Gastrointestinal Videoscope, 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
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
What you should do
- 1 Stop using EVIS EXERA III Gastrointestinal Videoscope 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
- November 15, 2023
- Units affected
- Not reported
- Sold at
- Nationwide Distribution.
- Recall number
- FDA-Z-0288-2024
- 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 903rd Health recall we've logged in 2023.