Class II — Uromedica Inc.
| Recalling firm | UROMEDICA, INC. |
|---|---|
| Registered facility | UROMEDICA, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths. |
| Product | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced. |
| Quantity | 11 tool sets |
| Distribution | Nationwide distribution to the following states: CA, GA, FL, MI, and VA. |
| Initiated | 2019-04-10 |
| Classified | 2020-04-28 |
| Terminated | 2020-05-18 |
| Recall number | Z-1808-2020 |
| 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-1808-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85486/
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