Class II — Uromedica Inc.
| Recalling firm | UROMEDICA, INC. |
|---|---|
| Registered facility | UROMEDICA, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. |
| Product | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile. |
| Quantity | 18 devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI. |
| Initiated | 2021-11-22 |
| Classified | 2022-01-05 |
| Terminated | 2023-08-11 |
| Recall number | Z-0458-2022 |
| 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 — Uromedica Inc. (Z-0458-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89184/
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