Scholly Fiberoptic Gmbh recalls UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cys…

Recall date

June 23, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2364-2023

FDA classification

Class II

Brand / firm

Scholly Fiberoptic Gmbh

Sold / distributed

Nationwide Foreign: Japan, South Korea

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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