Recall archive / FDA device enforcement
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool — FDA record Z-1502-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 24, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
- Reason
- There is the potential that during implant deployment, the device may not properly deliver a implant.
- Classification
- Class II
- Recalling firm
- Neotract Inc
- Quantity
- 18,722 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1502-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Wisconsin
- West Virginia
Dates in the source
- Report date
- Aug 10, 2022
- Recall initiation date
- Jun 24, 2022
- Center classification date
- Aug 4, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.