Z-1502-2022Class II

UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool

Name: Z-1502-2022 UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Creator: Neotract Inc
Published: 2022-06-24
License: https://open.fda.gov/license/

Neotract Inc / initiated 2022-06-24 / Open, Classified

FDA source

Neotract Inc began a recall of UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool on 2022-06-24. FDA classified it as Class II and gives the reason as "There is the potential that during implant deployment, the device may not properly deliver a implant". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1502-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-24
Posted: 2022-08-05
Recalling firm: Neotract Inc
Product: UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Product code: PEW Implantable Transprostatic Tissue Retractor System
Reason for recall: There is the potential that during implant deployment, the device may not properly deliver a implant.
FDA root cause: Under Investigation by firm
Action: Between the dates of June 28-29, 2022, NeoTract, Inc. (a subsidiary of Teleflex Inc.) issued a "Urgent Medical Device Recall" notification to affected consignees via UPS. On July 29,2022 NeoTract, Inc. sent an updated recall notification for additional lots that were affected. NeoTract asked consignees to take the following actions: 1. If you have affected stock: a. Immediately discontinue use and quarantine any products with the lot numbers listed above, so that the affected products can be returned to Teleflex. Lot numbers are printed on the product shelf carton and Tyvek labels (refer to attached appendix demonstrating how you can locate the lot numbers and part catalog numbers for these products) b. Please return the affected products as follows as soon as possible: c. Complete the enclosed Recall Acknowledgement Form and email back to [email protected]. This will allow us to document the number of affected products you have on hand for return. A customer service representative will issue you a Return Goods Authorization (RGA) Number and will provide instructions for returning the products to Teleflex. d. Attach the RGA Number to the affected product and follow the shipping instructions provided by Teleflex customer service. 2. If you have no affected stock: a. Please complete the enclosed Recall Acknowledgement Form and email back to [email protected]. This will allow us to document your receipt of this letter. 3. Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service at (866) 396-2111 or may also be reported to the FDA s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by fax to 1-800-FDA (332)-0178 or by phone, 1- 800-FDA (332)-1088.
Quantity in commerce: 18,722 systems
Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV OUS: None
Product codes and lots: UDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473 New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1502-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1502-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-04

Product code PEW

K193269Class IIUroLift System (UL400)Neotract, Inc. / cleared 2019-12-20

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)