Changchun Wancheng Bio-Electron Co., Ltd.: Medical Device Recall in 2026 - (Recall #: Z-1262-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Male Fertility Sperm Test for Home Use (Cassette)

Product Classification:

Class II

Date Initiated: November 22, 2025

Date Posted: February 11, 2026

Recall Number: Z-1262-2026

Event ID: 97801

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.

Status: Ongoing

Product Quantity: 1,000

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated