UroLift Visual Obturator (Scholly Fiberoptic) – Weld Defect (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany
Lot Codes / Batch Numbers
UDI-DI: 04250480106617 Lot Number: 141980
Products Sold
UDI-DI: 04250480106617 Lot Number: 141980
Scholly Fiberoptic Gmbh Robert-Bosch-Str. 1-3 Denzlingen Germany is recalling UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for due to There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fractur. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
SCHOLLY FIBEROPTIC GMBH initiated Recall Plan Letter to Users, Importers and Distributors . The US Distributor- Teleflex (parent company of NeoTract) notified on June 23, 2023 to forward the notification letter to their customers. Letter states reason for recall, health risk and action to take: Review this Field Safety Notice in its entirety and ensure that all users of the above-mentioned product in your organization and other concerned persons are informed about this Field Safety Notice. 2. If you are a distributor, please forward this correction notification to your customers. 3. Identify, quarantine and return affected devices. 4. Do not use affected devices anymore. 5. Exchange devices from the above-mentioned batches, which are currently in use. 6. Confirm receipt of this information by filling in the attached reply form and returning it to the indicated e-mail address. E-Mail: vigilance@schoelly.de
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026