# FDA recall Z-0458-2022

> **Uromedica Inc.** · Class II · device recall initiated 2021-11-22.

## 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.

## Distribution

US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.

## Key facts

- **Recall number:** Z-0458-2022
- **Recalling firm:** Uromedica Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-22
- **Report date:** 2022-01-12
- **Termination date:** 2023-08-11

- **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-0458-2022

## Citation

> AI Analytics. FDA recall Z-0458-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0458-2022. Source: US FDA. Licensed CC0.

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