Changchun Wancheng Bio-Electron Co., Ltd. recalls Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
- Recalling company
- Changchun Wancheng Bio-Electron Co., Ltd.
- Product
- Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 22, 2025
- Reported
- Feb 11, 2026
- Distribution
- US Nationwide distribution in the states of TX, GA, CA.
- Status
- Ongoing
- Quantity
- 4,800
- Lot / codes
- Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
- Company location
- Changchun, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1263-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1263-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.