# FDA recall Z-1808-2020

> **Uromedica Inc.** · Class II · device recall initiated 2019-04-10.

## 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.

## Distribution

Nationwide distribution to the following states: CA, GA, FL, MI, and VA.

## Key facts

- **Recall number:** Z-1808-2020
- **Recalling firm:** Uromedica Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-10
- **Report date:** 2020-05-06
- **Termination date:** 2020-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1808-2020

## Citation

> AI Analytics. FDA recall Z-1808-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1808-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*