ProACT Implantation Instrument Set — Class II medical device recall Z-1808-2020
Terminated recall by Uromedica Inc., reported 2020-05-06, distributed nationwide. Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Aff
| Recall number | Z-1808-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Uromedica Inc., Plymouth, MN, United States |
| Recall initiated | 2019-04-10 |
| Classified | 2020-04-28 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2020-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 11 tool |
| Lot numbers | UM00650 |
| Model numbers | 750041 |
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.
Reason for recall
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.
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-1808-2020. 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.