Class II
Medical Device Recall: Menopause Test Cassette (Urine)
Changchun Wancheng Bio-Electron Co., Ltd. · November 22, 2025
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of TX, GA, CA.
States Affected
NATIONWIDE
Quantity Affected
1,000
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1260-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.