Recall archive / FDA device enforcement
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6 — FDA record Z-1263-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 2 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1263-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 04953170340802 Serial Number: 2836210 2834747I |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
CA FL MA MD MI NJ OH PR WI
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 22, 2022
- Recall initiation date
- Apr 20, 2022
- Center classification date
- Jun 13, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.