Recall Z-2364-2023— Scholly Fiberoptic Gmbh

Name: FDA recall Z-2364-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-23

Class II · Ongoing

Class II FDA medical device recall by Scholly Fiberoptic Gmbh, initiated 2023-06-23. It names one FDA 510(k) clearance: K150158. 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: 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..

Recalling firm: Scholly Fiberoptic Gmbh
Classification: Class II
Status: Ongoing
Initiated: 2023-06-23
Firm location: Denzlingen, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K150158 — Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH·cleared 2015-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.