Exploro Male Fertility and Sperm Concentration Tests Recalled Due to Lack of FDA Clearance

What Happened

Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of its Exploro Highly Sensitive Male Fertility / Sperm Concentration Tests. The recall was triggered because the test strips and diagnostic components were distributed to U.S. customers before obtaining the necessary 510(k) clearance required for legal marketing. According to the FDA, these unvetted devices may produce false or inaccurate diagnostic results when used by consumers, which could lead to inappropriate medical interventions.

Which Products Are Affected

The recall involves approximately 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test. The affected products were distributed nationwide, with specific distribution confirmed in Texas, Georgia, and California.

The following lot numbers and expiration dates are included in this recall:

• Lot 2025033101: Expiration 03-30-2027
• Lot 2025080801: Expiration 08-07-2027
• Lot 2025090844: Expiration 09-07-2027

What You Should Do

Consumers who possess the affected test kits should stop using them immediately. The manufacturer began notifying customers of the issue via letter on November 22, 2025. Users who have already performed tests using these kits should consult with a healthcare professional to verify results using FDA-cleared diagnostic tools. For information regarding returns or refunds, consumers should contact Changchun Wancheng Bio-Electron Co., Ltd. at their headquarters in Changchun, China, or reach out to the original point of purchase.

Why This Matters

Diagnostic tests that have not undergone the required FDA review process pose a safety risk because their accuracy cannot be guaranteed. Inaccurate fertility results may cause significant emotional distress or lead individuals to pursue unnecessary or incorrect medical treatments.

Source

Information provided by the FDA under recall number Z-1263-2026.