FDA Device recall Z-2364-2023
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system
- FDA Device
- Class II
- ongoing
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class II recall of UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system by Scholly Fiberoptic, citing 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 occ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2364-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-23 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Scholly Fiberoptic |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | UDI-DI: 04250480106617 Lot Number: 141980 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2364-2023%22
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