# FDA recall Z-1263-2026

> **Changchun Wancheng Bio-Electron Co., Ltd.** · Class II · device recall initiated 2025-11-22.

## Product

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1263-2026
- **Recalling firm:** Changchun Wancheng Bio-Electron Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-22
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Changchun, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1263-2026

## Citation

> AI Analytics. FDA recall Z-1263-2026. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1263-2026. Source: US FDA. Licensed CC0.

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