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
- Menopause Test Cassette (Urine)
- Model numbers
- Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)
- 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 Menopause Test Cassette (Urine) is designed to help women self-test for menopause indicators. Consumers purchase these tests for convenience and privacy in managing their health.
Why This Is Dangerous
The hazard arises from the lack of proper FDA clearance, leading to false or inaccurate test results that could mislead users regarding their health status.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall poses a high risk for consumers who may rely on these results for health decisions, potentially leading to inappropriate medical interventions.
Practical Guidance
How to identify if yours is affected
- Check the model number: GT-FSH 20251601
- Verify the expiration date: May 2027
- Review the recall letter for specific instructions
Where to find product info
The model number and expiration date are typically located on the packaging or the test cassette itself.
What timeline to expect
Expect processing for refunds or replacements to take 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact customer service for follow-up
- Reach out to the FDA for assistance
- Document all communication attempts
How to prevent similar issues
- Always check for FDA approval or 510(k) clearance before purchasing medical devices
- Look for reliable brands with documented safety records
- Read user reviews and consult healthcare providers before use
Documentation advice
Keep a copy of the recall notice, any correspondence with the manufacturer, and receipts for your records.
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Product Details
The recalled product is the Menopause Test Cassette (Urine), model GT-FSH 20251601 with an expiration date of May 2027. The product was distributed nationwide in the U.S., specifically in Texas, Georgia, and California.
Key Facts
- Recall date: November 22, 2025
- Quantity recalled: 1,000 units
- Affected states: Texas, Georgia, California
- Potential for false diagnostic results
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Safety Guide
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