Reported Jun 22, 2022 · Ongoing
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
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 URETERO-RENO FIBERSCOPE ModelURF-P6
- Lot codes and dates
- UDI-DI04953170340802
- Serial Number2836210 2834747I
- Amount recalled
- 2 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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