Z-1116-2022 Class II Ongoing
FDA device recall Z-1116-2022 was initiated by Olympus Corporation Of The Americas on Mar 25, 2022 and is designated Class II. Reason for recall: The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section. The recall status is ongoing. Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Mar 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Olympus Uretero-reno videoscope, Model No. URF-V2
Reason for Recall
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
Distribution Pattern
US Nationwide distribution in the state of AZ.
Code Information
1 unit, serial number 2825505F UDI 04953170343582
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1116-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026