Changchun Wancheng Bio-Electron Recalls Male Fertility Sperm Tests Due to Lack of FDA Clearance

Source: FDA · United States

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Changchun Wancheng Bio-Electron Co., Ltd. is recalling 1,000 home sperm test kits distributed in the U.S. because the devices were marketed without required regulatory approval.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 17, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of its Male Fertility Sperm Test for Home Use (Cassette). The recall was prompted because the test strips and diagnostic components were distributed to U.S. customers before they could be legally marketed through the required 510(k) clearance process. According to the FDA, these unapproved devices may produce false or inaccurate diagnostic results, which could lead consumers to pursue inappropriate medical interventions.

Which Products Are Affected

The recall involves approximately 1,000 units of the following product:

  • Product Name: Male Fertility Sperm Test for Home Use (Cassette)
  • Lot Number: GT-SPA 20251601
  • Expiration Date: 05-2027
  • Recall Number: Z-1262-2026

The affected products were distributed nationwide within the United States, with confirmed distribution in Texas, Georgia, and California.

What You Should Do

Consumers who have purchased the affected test kits should stop using them immediately. The recalling firm, Changchun Wancheng Bio-Electron Co., Ltd., initiated the notification process via letter. Consumers seeking information regarding returns or refunds should contact the firm at their headquarters at 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, China.

Why This Matters

The use of diagnostic tests that have not been cleared by the FDA poses a risk of inaccurate health data. Inaccurate results from a fertility test could lead to incorrect self-diagnosis and unnecessary or harmful medical decisions.

Source

Information provided by the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Changchun Wancheng Bio-Electron Co., Ltd. is recalling 1,000 home sperm test kits distributed in the U.S. because the devices were marketed without required regulatory approval.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.