Exploro Highly Sensitive Male Fertility / Sperm recall
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Why was Exploro Highly Sensitive Male Fertility / Sperm recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
- Product
- Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
- Recalling firm
- Changchun Wancheng Bio-Electron Co., Ltd.
- Quantity
- 4,800
- Distribution
- US Nationwide distribution in the states of TX, GA, CA.
- Recall date
- February 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)