UroLift Visual Obturator — Class II medical device recall Z-2364-2023
Ongoing recall by Scholly Fiberoptic Gmbh, reported 2023-08-16, distributed nationwide. There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanica
| Recall number | Z-2364-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Scholly Fiberoptic Gmbh, Denzlingen, N/A, Germany |
| Recall initiated | 2023-06-23 |
| Classified | 2023-08-09 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, KR |
| Quantity | 98 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04250480106617 |
| Lot numbers | 141980 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2364-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.