Z-2519-2018 Class II Terminated
FDA device recall Z-2519-2018 was initiated by Olympus Corporation Of The Americas on Jan 17, 2018 and is designated Class II. Reason for recall: Breakage of the endoscope's insertion tube bending section during surgical procedures. The recall status is terminated (terminated Dec 4, 2019). Affected quantity: 1062.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2018
- Initiation Date
- Jan 17, 2018
- Termination Date
- Dec 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1062
Product Description
Uretero-reno fiberscope URF-P6
Reason for Recall
Breakage of the endoscope's insertion tube bending section during surgical procedures.
Distribution Pattern
US Nationwide. Canada and Mexico
Code Information
All serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2519-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026