Recall Weekly
Moderate riskFDA DeviceClass II

Exploro male fertility test recalled for inaccurate result risk

Exploro Highly Sensitive Male Fertility test strips were sold in the U.S. before receiving required FDA approval. These tests may give false or inaccurate results when used at home, potentially leading to unnecessary or inappropriate medical decisions.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using Exploro fertility test strips immediately
  2. Check your test kit for lot numbers 2025033101, 2025080801, or 2025090844
  3. Do not rely on results from these tests for medical decisions
  4. Contact your doctor if you've already used this test and made health decisions based on the result
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 11 products — see all of them.

Details

Units affected
4,800
Illnesses reported
None reported
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Classification
Class II
Recall number
Z-1263-2026

In the FDA's words

Description
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test 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. Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 4,800
Hazard
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.

11 products in this recall

LotFancy, Vivoo and URIMED urine test strips recalled over unauthorized marketing

Changchun Wancheng is recalling 11 product listings of home test strips and diagnostic tests, including urinary tract infection, ovulation, menopause, fertility and Vivoo tests. The devices were distributed in the U.S. before FDA clearance (510(k)), and they may give false or inaccurate results to users, which could lead to inappropriate medical treatment. The recall was distributed nationwide, with confirmed distribution in Texas, Georgia and California.

The agency lists each product separately. Check every one you might have.

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