Class II — Neotract Inc
| Recalling firm | NEOTRACT, INC. |
|---|---|
| Registered facility | NEOTRACT, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is the potential that during implant deployment, the device may not properly deliver a implant. |
| Product | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool |
| Quantity | 18,722 systems |
| 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 |
| Initiated | 2022-06-24 |
| Classified | 2022-08-04 |
| Recall number | Z-1502-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Neotract Inc (Z-1502-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90548/
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