# FDA recall Z-2364-2023

> **Scholly Fiberoptic Gmbh** · Class II · device recall initiated 2023-06-23.

## 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.

## Distribution

Nationwide Foreign: Japan, South Korea

## Key facts

- **Recall number:** Z-2364-2023
- **Recalling firm:** Scholly Fiberoptic Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-23
- **Report date:** 2023-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Denzlingen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2364-2023

## Citation

> AI Analytics. FDA recall Z-2364-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2364-2023. Source: US FDA. Licensed CC0.

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