Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

UroLift Visual Obturator Recalled by Scholly Fiberoptic Gmbh Due to There is an improperly performed weld between the...

Date: June 23, 2023
Company: Scholly Fiberoptic Gmbh
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Scholly Fiberoptic Gmbh directly.

Affected Products

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

Quantity: 98 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Scholly Fiberoptic Gmbh

Scholly Fiberoptic Gmbh has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report