LH One Step Ovulation Test Device — Class II medical device recall Z-1259-2026
Ongoing recall by Changchun Wancheng Bio-Electron Co., Ltd., reported 2026-02-11, distributed nationwide. Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before
| Recall number | Z-1259-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Changchun Wancheng Bio-Electron Co., Ltd., Changchun, N/A, China |
| Recall initiated | 2025-11-22 |
| Classified | 2026-02-04 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,000 |
Product
LH One Step Ovulation Test Device (Urine)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1259-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.