Reported Jun 22, 2022 · Ongoing
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
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?
- Olympus CYSTONEPHROFIBERSCOPE ModelCYF-5
- Lot codes and dates
- UDI-DI04953170339417
- Serial Number2456630 7171632 2769732 W501648A 2355088 2557155 2972060
- Amount recalled
- 7 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
This product could cause temporary or reversible health problems — stop using it.
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