Reported Aug 10, 2022 · Ongoing

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

Neotract Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Neotract Inc · 4155 Hopyard Rd · Pleasanton, CA · 94588-8534

Is this the product you have?

  • UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Lot codes and dates
  • UDI/DI00814932020049 & 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
Amount recalled
18,722 systems

Where it was sold

Why it was recalled

There is the potential that during implant deployment, the device may not properly deliver a implant.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.