UroLift System REF UL400-4 — Class II medical device recall Z-1502-2022
Ongoing recall by Neotract Inc, reported 2022-08-10, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. There is the potential that during implant deployment, the device may not properly deliver a implant.
| Recall number | Z-1502-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neotract Inc, Pleasanton, CA, United States |
| Recall initiated | 2022-06-24 |
| Classified | 2022-08-04 |
| Reported by FDA | 2022-08-10 |
| Distributed | 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 |
| Quantity | 18,722 systems |
| UPC / GTIN / UDI-DI | 00814932020001, 00814932020049 |
| Lot numbers | 73A2200012, 73A2200013, 73A2200014, 73A2200221, 73A2200222, 73A2200223, 73A2200224, 73A2200225, 73A2200226, 73A2200473, 73A2200670, 73A2200671, 73A2200672, 73A2200673, 73A2200674, 73A2200832, 73A2200841, 73A2200859, 73A2200905, 73B2200116, 73B2200466, 73C2200567, 73M2100393, 73M2100394, 73M2100395 |
| Model numbers | UL400-4 |
Product
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Reason for recall
There is the potential that during implant deployment, the device may not properly deliver a implant.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1502-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.