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
- Male Fertility Sperm Test
- Model numbers
- Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 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 Male Fertility Sperm Test for Home Use is designed for individuals seeking to assess their fertility levels conveniently at home. Consumers typically purchase this product to gain insights into their reproductive health without the need for professional testing.
Why This Is Dangerous
The hazard arises from the device being distributed without the necessary FDA clearance, leading to the potential for inaccurate results. Users may misinterpret these results, prompting inappropriate medical decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face significant implications from using inaccurate test results, potentially impacting their health decisions and leading to unnecessary stress.
Practical Guidance
How to identify if yours is affected
- Check the packaging for the model number GT-SPA 20251601.
- Verify the expiration date is May 2027.
- Look for any recall notices received by mail.
Where to find product info
The model number and expiration date can typically be found on the product packaging or instruction manual.
What timeline to expect
Expect up to 4-6 weeks for refund processing once the manufacturer receives the product back.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Consider contacting the FDA if the manufacturer does not respond.
How to prevent similar issues
- When purchasing medical devices, check for FDA clearance.
- Look for reviews and validation from healthcare professionals before buying.
- Be cautious of products that lack clear regulatory compliance.
Documentation advice
Keep copies of any letters from the manufacturer and your correspondence regarding the recall.
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Product Details
The recalled product is the Male Fertility Sperm Test for Home Use (Cassette), model GT-SPA 20251601 with an expiration date of May 2027. It was distributed nationwide in Texas, Georgia, and California.
Key Facts
- Distributed in TX, GA, CA
- Risk of false diagnostic results
- Affected model: GT-SPA 20251601
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Safety Guide
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