Medical Device Recall: UroLift Visual Obturator Weld Defect Risk
The UroLift Visual Obturator has an improperly performed weld that may fracture during use, and the welded area can harbor contamination not removed by standard cleaning. Affected units should not be used.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical invasive medical device with a documented mechanical weld defect that may fracture during use and harbor contamination. The source text reports no injuries or illnesses to date, which per the rubric limits the score to High (3), though the potential for patient harm in an invasive urological procedure is significant.
Plain-English summary
The UroLift Visual Obturator (Model UL-VO) is a medical instrument used with the UroLift system to insert a cystoscope shaft into the bladder during procedures. Scholly Fiberoptic Gmbh is recalling 98 units distributed nationwide and internationally (Japan and South Korea, Lot 141980, UDI-DI: 04250480106617).
The recall was issued because of an improperly performed weld between the cone of the sheath lock and the tube of the obturator. This weld defect reduces the mechanical load capacity of the instrument, creating a risk that the welded joint may fracture during use. Additionally, a small capillary gap exists at the weld site that can become contaminated; this contamination is not effectively removed by standard reprocessing and cleaning procedures.
Healthcare facilities and providers using these devices should stop using the affected units immediately and contact Scholly Fiberoptic Gmbh for instructions on return or replacement.
The recalled product
- 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
- Manufacturer
- Scholly Fiberoptic Gmbh
- Hazard
- weld-defect
- fracture-risk
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04250480106617 Lot Number: 141980
Distribution
Distributed nationwide across the United States.
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