CLASS II ONGOING Device recall · Reported 16 Aug 2023 · FDA Enforcement Report
UroLift Visual Obturator, 20Ch-The visual obturator is used recalled
Scholly Fiberoptic is recalling UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system, distributed nationwide in the US. The recall was initiated on 23 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2364-2023
- FDA event ID
- 92700
- Recalling firm
- Scholly Fiberoptic, Denzlingen, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jun 2023
- FDA classified
- 9 Aug 2023
- Reported
- 16 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 23 Jun 2023 | Recall initiated by company | |
| 9 Aug 2023 | Classified by FDA | +47 days |
| 16 Aug 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide Foreign: Japan, South Korea
Questions about this recall
Is UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system recalled?
Yes. Scholly Fiberoptic recalled UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system on 23 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2364-2023.
Why was it 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.
Which lots are affected?
UDI-DI: 04250480106617 Lot Number: 141980
Where was it sold?
Nationwide Foreign: Japan, South Korea
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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