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
- Ovulation Test Device
- Model numbers
- Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 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 LH One Step Ovulation Test Device is designed to help individuals track their ovulation cycle. It is commonly used by those trying to conceive to identify fertile windows.
Why This Is Dangerous
The devices were distributed without proper regulatory approval, which raises concerns about their accuracy. Inaccurate results could mislead users and lead to inappropriate medical actions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face inconvenience and potential health risks due to reliance on inaccurate test results.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging.
- Verify the expiration date, which should be no later than May 2027.
- Look for any notification letters from the manufacturer.
Where to find product info
Serial numbers and lot information are typically located on the packaging or user manual.
What timeline to expect
Expect a refund processing time of approximately 4-6 weeks after submission of your request.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Consider contacting consumer protection agencies for assistance.
How to prevent similar issues
- Look for FDA-approved ovulation tests in the future.
- Check for proper labeling and regulatory compliance before purchase.
- Consult healthcare providers for recommendations on reliable products.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and photographs of the product as evidence.
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Product Details
The LH One Step Ovulation Test Device (Urine), model GT-LH 20251601, was distributed nationwide. The affected lot has an expiration date of May 2027.
Key Facts
- Recall date: November 22, 2025
- Distribution: Texas, Georgia, California
- Quantity recalled: 1,000 devices
- Potential for false diagnostic results
- Manufacturer contact: Changchun Wancheng Bio-Electron Co., Ltd.
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Safety Guide
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