Reported Feb 11, 2026 · Ongoing
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Changchun Wancheng Bio-Electron Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Changchun Wancheng Bio-Electron Co., Ltd. · 2336, Tianwei Road · Changchun, N/A · N/A
Is this the product you have?
- Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
- Lot codes and dates
- Name/Lot(Expiration)Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
- Amount recalled
- 4,800
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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