Exploro Highly Sensitive Male Fertility / Sperm Concentration Test recall (Changchun Wancheng Bio-Electron Co., Ltd.)
Medical deviceClass IIOngoing
Summary: Changchun Wancheng Bio-Electron Co., Ltd. is recalling Exploro Highly Sensitive Male Fertility / Sperm Concentration Test. Reason: 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.
What is being recalled
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of TX, GA, CA. (states named: California, Georgia, Texas)
How to tell if yours is affected
Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1263-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 22, 2025 |
| Reported | February 11, 2026 |
| Company | Changchun Wancheng Bio-Electron Co., Ltd. |
| Company location | Changchun, N/A, China |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4,800 |
More recalls from Changchun Wancheng Bio-Electron Co., Ltd. · all medical device recalls · recalls from November 2025