Z-1263-2022 Class II Ongoing
FDA device recall Z-1263-2022 was initiated by Olympus Corporation Of The Americas on Apr 20, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 22, 2022
- Initiation Date
- Apr 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
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.
Distribution Pattern
CA FL MA MD MI NJ OH PR WI
Code Information
UDI-DI: 04953170340802 Serial Number: 2836210 2834747I
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1263-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026