Olympus Corporation of the Americas 2024-11-20 Health serious FDA
Health · FDA · Recall #FDA-Z-0351-2025
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number:… Recall
Issued November 20, 2024 · Olympus Corporation of the Americas
In November 2024, Olympus Corporation of the Americas recalled the Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number:…, 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
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
What you should do
- 1 Stop using Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number:… 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 20, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS
- Recall number
- FDA-Z-0351-2025
- 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 737th Health recall we've logged in 2024.