Z-2364-2023 Class II Ongoing
FDA device recall Z-2364-2023 was initiated by Scholly Fiberoptic Gmbh on Jun 23, 2023 and is designated Class II. Reason for recall: There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can… The recall status is ongoing. Affected quantity: 98 units.
Recall details
- Product Type
- Devices
- Report Date
- Aug 16, 2023
- Initiation Date
- Jun 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 units
Product description
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO
Reason for recall
There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.
Distribution pattern
Nationwide Foreign: Japan, South Korea
Code information
UDI-DI: 04250480106617 Lot Number: 141980
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2364-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026