FDA-Device2026-02-11Class IIMISBRANDING
Exploro male fertility test strips recalled for inaccurate results without FDA approval
What this means
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.
- Stop using Exploro fertility test strips immediately
- Check your test kit for lot numbers 2025033101, 2025080801, or 2025090844
- Do not rely on results from these tests for medical decisions
- Contact your doctor if you've already used this test and made health decisions based on the result
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of TX, GA, CA.
Affected count
4,800
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1263-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.