UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift… — Class II medical device recall Z-0598-2019
Terminated recall by Neotract Inc, reported 2018-12-19, distributed in AK, AL, AZ, CA, CO, CT, DE, FL…. Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mod
| Recall number | Z-0598-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neotract Inc, Pleasanton, CA, United States |
| Recall initiated | 2018-07-06 |
| Classified | 2018-12-12 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-12-02 |
| Distributed | AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV |
| Quantity | 8,804 |
| Reason classes | device malfunction |
| Lot numbers | P37940, P37943, P37953, P37956, P37965, P37971, P37985, P37988, P37995, P38001, P38013, P38020, P38124, P38132 |
| Model numbers | AN00141, UL400-4 |
Product
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
Reason for recall
Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. Failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.
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-0598-2019. 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.