FDAFDA · Food and drugs·Recall number Z-1262-2026
Male Fertility Sperm Test for Home Use (Cassette)
Published February 11, 2026 · Recall initiated: November 22, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Changchun Wancheng Bio-Electron Co., Ltd.
- Distributor
- US Nationwide distribution in the states of TX, GA, CA.
- Lot
- Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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