Scholly Fiberoptic recalls UroLift Visual Obturator (UL-VO) due to potential weld failure causing fracture and contamination risks. Affected units sold with lot number 141980.
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.
Scholly Fiberoptic is recalling UroLift Visual Obturator instruments because a weld failure could cause the device to fracture during use, potentially leading to contamination. This affects medical devices used in bladder procedures.
The obturator has an improperly welded joint that can fracture under mechanical stress. This fracture risk could lead to contamination in the device's capillary gap, which isn't covered by standard reprocessing checks.
Medical professionals using the UroLift system for bladder procedures are most at risk. Patients receiving the procedure may also be affected if the device fractures during use.
Check for model UL-VO with lot number 141980. The device is used with the UroLift system for inserting cystoscope shafts into the bladder.
Look for model UL-VO and lot number 141980 on the device packaging or label.
Reach out to Scholly Fiberoptic directly for further guidance on the recall.
The recall indicates a potential weld failure risk, so it is not recommended for use until the manufacturer provides further instructions.
Check the model and lot number to confirm if it's affected; contact Scholly Fiberoptic for next steps.
The recall record does not specify replacement options or remedies.
We’ve drafted a message you can send Scholly Fiberoptic to request your refund or repair — edit it as you like.
Subject: Recall Z-2364-2023 — Scholly Fiberoptic Scholly Fiberoptic Hello, I own a Scholly Fiberoptic that is covered by recall Z-2364-2023 from Scholly Fiberoptic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
