The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1952-2019·Announced 2019-07-17

Rinovum Recalls Revive Reusable Bladder Support Due to Structural Defect

Rinovum Women's Health is recalling the Revive Reusable Bladder Support because the device may split or crack during its intended use life.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (splitting or cracking) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Rinovum Women's Health is recalling the Revive Reusable Bladder Support, Model No. 0025. The recall involves 1,024 units, of which 180 were distributed from a distributor. The product was distributed nationwide in the states of Alabama, California, Colorado, Florida, Georgia, Indiana, Kentucky, Montana, New York, Ohio, Pennsylvania, South Carolina, and Wyoming.

The recall was initiated because the product is unable to meet the intended use life of 31 cycles. The device may split or crack at the base of the "petals" after repeated use, but within the product's stated use life of 31 uses. The device is intended for the temporary management of urinary leakage caused by stress urinary incontinence in women aged 18 and older.

Consumers should stop using the device and contact Rinovum Women's Health for further instructions. The device is nonperishable and does not have an expiration date.

The recalled product

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…
Manufacturer
Rinovum Women's Health
Category
Medical Device — Incontinence Management
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 75770223

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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