Olympus Corporation of the Americas 2022-06-29 Health serious FDA
Health · FDA · Recall #FDA-Z-1275-2022
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive… Recall
Issued June 29, 2022 · Olympus Corporation of the Americas
In June 2022, Olympus Corporation of the Americas recalled the EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive…, 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
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
What you should do
- 1 Stop using EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive… 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
- June 29, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AL, FL, NC, NY.
- Recall number
- FDA-Z-1275-2022
- 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.