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:
73M210039373A220067073M210039473A220067173M210039573A220067273A220001273A220067373A220001373A220067473A220001473A220083273A220022173A220084173A220022273A220085973A220022373A220090573A220022473B220011673A220022573B220046673A220022673C220056773A2200473
- New Lots added as of 08/01/2022
73A220083473C2200911and 73C2201163
- UDI/DI00814932020049 & 00814932020001; Lot #s:
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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