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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83023

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 02, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Rinovum Women's Health

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1952-2019
Recall number
Z-1952-2019
Initiated
May 02, 2019
Classification
Class II
Status
Terminated
Recalling firm
Rinovum Women's Health
Quantity
1024 (180 distributed from distributor)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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).

Code information

Lot 75770223

Distribution pattern

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