Rinovum Women's Health recalls Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary m…

Recall date

May 2, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1952-2019

FDA classification

Class II

Brand / firm

Rinovum Women's Health

Sold / distributed

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

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.