Scholly Fiberoptic Gmbh: Medical Device Recall in 2023 - (Recall #: Z-2364-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 23, 2023

Date Posted: August 16, 2023

Recall Number: Z-2364-2023

Event ID: 92700

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.

Status: Ongoing

Product Quantity: 98 units

Code Information:

UDI-DI: 04250480106617 Lot Number: 141980

Distribution Pattern:

Nationwide Foreign: Japan, South Korea

Voluntary or Mandated:

Voluntary: Firm initiated