Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 17, 2019
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.
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).
Rinovum Women's Health recalled Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder suppo… - a moderate-severity action.
Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder suppo… was recalled by Rinovum Women's Health in July 17, 2019. Reason: The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" af…. Check the official notice for the remedy. Verify recall #Z-1952-2019 with the FDA Devices before acting.
The recall
Rinovum Women's Health issued this moderate-severity FDA Devices recall-The product is unable to meet the use life of 31 cycles and may split or crack at the base of the "petals" af….
- Moderate
- severity level
- Class II
- classification
- July 17, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1952-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1952-2019) was formally reported on July 17, 2019, with the manufacturer initiating the action on May 2, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Rinovum Women's Health is listed as the recalling firm, operating out of Monroeville, PA. Federal records list the affected scope as 1024 (180 distributed from distributor).
The documented reason for this recall is: 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 data in the federal record shows the product reached: US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1024 (180 distributed from distributor)
Related Recalls
6
3 from same agency
Product description
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1952-2019 |
| Date reported | July 17, 2019 |
| Date initiated | May 2, 2019 |
| Recalling firm | Rinovum Women's Health |
| Firm location | Monroeville, PA |
| Affected scope | 1024 (180 distributed from distributor) |
| Distribution | US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1952-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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.. Recalled by Rinovum Women's Health. Units affected: 1024 (180 distributed from distributor).
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2019. Severity: Moderate. Recall number: Z-1952-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of Al, CA, CO, FL, GA, IN, KY, MT, NY, OH, PA, SC, and WY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1952-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 17, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.