Changchun Wancheng Bio-Electron recalls Exploro Highly Sensitive Male Fertility Test strips due to potential false results. Users may get incorrect results leading to unnecessary medical procedures. Check product labels for lot numbers ending in 2025033101, 2025080801, or 2025090844.
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.
Changchun Wancheng Bio-Electron recalled Exploro Highly Sensitive Male Fertility Test strips because they may give false results. This could lead to incorrect medical decisions and unnecessary treatments. The recall affects specific lot numbers sold between March 2025 and September 2025.
The test strips were distributed before receiving U.S. regulatory approval. This means they might not work correctly, leading to false results. False results could cause people to seek unnecessary medical care or treatments.
Men who use the Exploro fertility test strips for self-testing may be affected. Those with specific lot numbers (2025033101, 2025080801, 2025090844) are most at risk.
Check the product label for lot numbers ending in 2025033101, 2025080801, or 2025090844. These lots were sold between March 2025 and September 2025.
Look for lot numbers ending in 2025033101, 2025080801, or 2025090844 on the test strips.
The test strips were distributed before receiving U.S. regulatory approval, which may cause false results and lead to inappropriate medical interventions.
Lot numbers ending in 2025033101, 2025080801, and 2025090844 were sold between March 2025 and September 2025.
The recall does not require stopping use immediately; however, affected lot numbers should be checked and replaced if necessary.
We’ve drafted a message you can send Exploro to request your refund or repair — edit it as you like.
Subject: Recall Z-1263-2026 — Exploro Exploro Hello, I own a Exploro that is covered by recall Z-1263-2026 from Exploro. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
