Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R — Class II medical device recall Z-1264-2022
Ongoing recall by Olympus Corporation of the Americas, reported 2022-06-22, distributed in CA, FL, MA, MD, MI, NJ, OH, PR…. Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may r
| Recall number | Z-1264-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2022-04-20 |
| Classified | 2022-06-13 |
| Reported by FDA | 2022-06-22 |
| Distributed | CA, FL, MA, MD, MI, NJ, OH, PR, WI |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 04953170340833 |
| Serial numbers | 2835978, 2836209F, 2836299, 2837272 |
| Model numbers | URF-P6R |
Product
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1264-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.