Drug & Device Safety Atlas

FDA recall record · openFDA

Changchun Wancheng Bio-Electron Co., Ltd.

11 FDA recalls on record (2025) — 11 device. 11 still ongoing.

0
Class I (most serious)
11
Class II
0
Class III
11
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could 11

Recalls

Male Fertility Sperm Test for Home Use (Cassette) Class II 2025-11-22 Exploro Highly Sensitive Male Fertility / Sperm Concentration Test Class II 2025-11-22 Vivoo Protein Test Class II 2025-11-22 LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in Class II 2025-11-22 S. Typhi/Para Typhi A Antigen Class II 2025-11-22 The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Class II 2025-11-22 Vivoo pH Test Class II 2025-11-22 Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test Class II 2025-11-22 LH One Step Ovulation Test Device (Urine) Class II 2025-11-22 Menopause Test Cassette (Urine) Class II 2025-11-22 Vivoo Vaginal pH Test Class II 2025-11-22

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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