Exploro Male Fertility and Sperm Concentration Tests Recalled Due to Lack of FDA Clearance
According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.
Changchun Wancheng Bio-Electron Co., Ltd. is recalling 4,800 Exploro male fertility test kits because they were distributed without required legal marketing clearance.
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.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, medical-device) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.
What is this FDA recall about? ▾
Which agency issued this alert? ▾
How severe is this alert? ▾
What area is affected? ▾
Where can I find more FDA Recalls updates? ▾
Primary source data
EPA Outdoor Air Quality Data
Federal monitoring network — every measurement we report
AirNow (EPA / NOAA)
Real-time AQI for every monitored U.S. location
National Weather Service
Active watches, warnings, and advisories — NOAA
CDC Air Quality & Health
Health-impact reference behind every AQI category