Z-2364-2023Class II

UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion...

Name: Z-2364-2023 UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion...
Creator: Scholly Fiberoptic Gmbh
Published: 2023-06-23
License: https://open.fda.gov/license/

Schoelly Fiberoptic, GmbH / initiated 2023-06-23 / Open, Classified / root cause: manufacturing process

FDA source

Scholly Fiberoptic Gmbh began a recall of UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift system. Instrument for insertion of a cystoscope shaft into the bladder. Model... on 2023-06-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2364-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-23
Posted: 2023-08-09
Recalling firm: Schoelly Fiberoptic, GmbH
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
Product code: HIH Hysteroscope (And Accessories)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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: [email protected]
Quantity in commerce: 98 units
Distribution: Nationwide Foreign: Japan, South Korea
Product codes and lots: UDI-DI: 04250480106617 Lot Number: 141980

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2364-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2364-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-09

Product code HIH

K150158Class IISchoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH / cleared 2015-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)