UROMEDICA Implantation Instrument Set — Class II medical device recall Z-0458-2022
Terminated recall by Uromedica Inc., reported 2022-01-12, distributed nationwide. The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheat
| Recall number | Z-0458-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Uromedica Inc., Plymouth, MN, United States |
| Recall initiated | 2021-11-22 |
| Classified | 2022-01-05 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2023-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 18 devices |
| UPC / GTIN / UDI-DI | 00180668000106 |
| Lot numbers | UM00794, UM00817 |
| Model numbers | 750041 |
Product
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Reason for recall
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
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-0458-2022. 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.