# FDA recall Z-1952-2019

> **Rinovum Women's Health** · Class II · device recall initiated 2019-05-02.

## Product

Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable bladder support and applicator, and disposable strings and travel case. The device is nonperishable and does not have an expiration date.

## Reason for recall

The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" after repeated use but within the use life of the product (31 uses).

## Distribution

US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.

## Key facts

- **Recall number:** Z-1952-2019
- **Recalling firm:** Rinovum Women's Health
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-02
- **Report date:** 2019-07-17
- **Termination date:** 2019-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Monroeville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1952-2019

## Citation

> AI Analytics. FDA recall Z-1952-2019. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1952-2019. Source: US FDA. Licensed CC0.

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