Quick Facts at a Glance
- Recall Date
- November 22, 2025
- Hazard Level
- HIGH
- Brand
- Changchun Wancheng Bio-Electron Co.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Changchun Wancheng Bio-Electron Co.
- Product type
- Vaginal pH Test
- Model numbers
- Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026)
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 22, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Vivoo Vaginal pH Test allows consumers to check their vaginal pH levels at home, which can be useful for monitoring health. Consumers typically purchase these tests for personal health management and to understand vaginal health better.
Why This Is Dangerous
The test strips may yield inaccurate results, especially when used by individuals without medical training. This can lead to misinterpretation of results and unnecessary medical actions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers who purchased this test may face health risks due to inaccurate results. The need to stop use and return the product can also cause inconvenience.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the packaging or test strips.
- Check the expiration date; it should be before March 21, 2026.
- If the model matches Vivoo Vaginal pH Test/2024032219, it is affected.
Where to find product info
The model number is typically found on the packaging or the test strips themselves.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document your communication attempts with the manufacturer.
- Reach out to your healthcare provider for further guidance.
- Consider filing a complaint with the FDA if unresponsive.
How to prevent similar issues
- Choose FDA-approved testing devices in the future.
- Always verify the legality and approval status of health products before purchase.
- Consult healthcare professionals for reliable testing options.
Documentation advice
Keep a record of your purchase receipt, any correspondence with the manufacturer, and photos of the product.
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Product Details
The recall involves the Vivoo Vaginal pH Test, model Vivoo Vaginal pH Test/2024032219, with an expiration date of March 21, 2026. The product was distributed nationwide in the U.S. and is manufactured by Changchun Wancheng Bio-Electron Co. It was not legally marketed before its distribution.
Key Facts
- Distributed in TX, GA, CA
- Potential for false diagnostic results
- Class II medical device
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Safety Guide
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