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U.S. Department of Health and Human Services

Class 2 Device Recall Urolift Visual Obturator

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 Class 2 Device Recall Urolift Visual Obturatorsee related information
Date Initiated by FirmJune 23, 2023
Date PostedAugust 09, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2364-2023
Recall Event ID 92700
510(K)NumberK150158 
Product Classification Hysteroscope (and accessories) - Product Code HIH
ProductUroLift 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
Code Information UDI-DI: 04250480106617 Lot Number: 141980
FEI Number 3002808088
Recalling Firm/
Manufacturer		 Scholly Fiberoptic Gmbh
Robert-Bosch-Str. 1-3
Denzlingen Germany
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionSCHOLLY 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
Quantity in Commerce98 units
DistributionNationwide Foreign: Japan, South Korea
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HIH
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