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Male Fertility Sperm Test for Home Use (Cassette)

FDA Recall #Z-1262-2026 — Class II — November 22, 2025

Recall #Z-1262-2026 Date: November 22, 2025 Classification: Class II Status: Ongoing

Product Description

Male Fertility Sperm Test for Home Use (Cassette)

Reason for Recall

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.

Recalling Firm

Changchun Wancheng Bio-Electron Co., Ltd. — Changchun, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1,000

Distribution

US Nationwide distribution in the states of TX, GA, CA.

Code Information

Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027)

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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