FDA Medical devices recall ·
Menopause Test Cassette (Urine) recall
- Recall number
- Z-1260-2026
- Date
- (initiated November 22, 2025)
- Company / brand
- Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road, Changchun, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,000
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Menopause Test Cassette (Urine)
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)
Distribution
US Nationwide distribution in the states of TX, GA, CA.
States: California Georgia Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1260-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.