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
- Fertility Test Kit
- Model numbers
- Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
- 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 Exploro Highly Sensitive Male Fertility / Sperm Concentration Test is designed to help men assess their sperm concentration levels. Consumers typically buy this product to evaluate their fertility potential at home, offering privacy and convenience.
Why This Is Dangerous
The tests may provide false results due to distribution without proper regulatory clearance, which can mislead users in making health decisions. This can lead to unnecessary anxiety or incorrect medical interventions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face delays in obtaining accurate fertility assessments, which can affect their family planning decisions. The potential for misdiagnosis adds urgency to the recall.
Practical Guidance
How to identify if yours is affected
- Locate the lot number on your Exploro fertility test packaging.
- Check if your lot number matches 2025033101, 2025080801, or 2025090844.
- Verify the expiration date against the lot numbers.
Where to find product info
You can find the lot number and expiration date on the test box or the insert included with the product.
What timeline to expect
Expect to receive your refund within 4-6 weeks after submitting the return.
If the manufacturer is unresponsive
- Document your communication with the manufacturer, including dates and details.
- Reach out again using different contact methods if you do not receive a timely response.
- Consider filing a complaint with the FDA if the company remains unresponsive.
How to prevent similar issues
- Always check for FDA approval or clearance before purchasing medical devices.
- Research the manufacturer’s reputation and any historical recalls.
- Consult with a healthcare provider for recommendations on reliable fertility tests.
Documentation advice
Keep a record of your purchase receipt, any correspondence with the manufacturer, and photos of the product for your records.
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Product Details
The recalled product is the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test. The affected lot numbers include 2025033101, 2025080801, and 2025090844, with expiration dates ranging from March 30, 2027, to September 7, 2027. The tests were distributed nationwide in Texas, Georgia, and California.
Key Facts
- Hazard: False diagnostic results
- Affected states: TX, GA, CA
- Contact manufacturer for further instructions
- FDA recall notice available online
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Safety Guide
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