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Use caution Medical device recall · FDA · Published November 22, 2025

Recall: Changchun Wancheng Male Fertility Sperm Test Cassette

Changchun Wancheng recalls Male Fertility Sperm Test cassettes due to risk of false or inaccurate results leading to inappropriate medical intervention.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1262-2026Medical deviceChangchun Wancheng ›
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Contact the company

Recalling firmChangchun Wancheng Bio-Electron Co., Ltd.2336, Tianwei Road, Beihu Science and Technology Development Zone · Changchun, China
✎ GovInfoNow plain-language explainer

Changchun Wancheng Bio-Electron Co., Ltd. is recalling the Male Fertility Sperm Test for Home Use (Cassette) because the devices were distributed before they could be legally marketed in the U.S. The primary concern is that these tests may produce false or inaccurate diagnostic results when used by lay persons. This inaccuracy could potentially lead to inappropriate medical interventions based on incorrect information. Read more at govinfonow.com/recall/50620-male-fertility-sperm-test-for-home-use-false-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/50620-male-fertility-sperm-test-for-home-use-false-results-risk · Updated October 13, 2026 · FDA enforcement record: FDA #Z-1262-2026

Cite this page

“Recall: Changchun Wancheng Male Fertility Sperm Test Cassette.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/50620-male-fertility-sperm-test-for-home-use-false-results-risk. Based on FDA recall #Z-1262-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1262-2026%22&limit=1).

The FDA announced on Nov. 22, 2025, that Changchun Wancheng Bio-Electron Co., Ltd. is recalling its Male Fertility Sperm Test for Home Use (Cassette) because the devices were distributed before legal marketing approval. The agency warns these tests may produce false or inaccurate results, potentially leading to inappropriate medical intervention.

How to tell if you have it

  • Brand: Changchun Wancheng Bio-Electron
  • Product: Male Fertility Sperm Test for Home Use (Cassette)
  • Lot/Expiration: GT-SPA 20251601(05-2027)
  • Quantity: 1,000 units
  • Distribution: Nationwide in TX, GA, CA

The hazard

According to the FDA, the test strips and other tests requiring a 510(k) were distributed before they could be legally marketed to U.S. customers. The agency states these devices may cause false or inaccurate diagnostic results by lay persons and lead to inappropriate medical intervention.

Context

GovInfoNow's records show other recent recalls of similar products include GET TESTED Sperm Test Recall: Distribution Without Premarket Approval (2025-11-03), GET TESTED Sperm Test: Distribution Without Premarket Approval (2025-11-03), and Female Fertility Test Recall: Distribution Without Premarket Approval (2025-11-03).

How to tell if you have this one

Check if you have the Male Fertility Sperm Test for Home Use (Cassette). The specific product name and lot information is GT-SPA 20251601 with an expiration date of 05-2027. These units were distributed nationwide in the states of TX, GA, and CA.

  • Brand
    Changchun Wancheng
  • Category
    Medical device
FDA recall event · 11 products

All 11 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of TX, GA, CA.
Recall numberProduct, codes & lotsQuantity
Z-1257-2026LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI); Name/Lot(Expiration): LotFancy Urinary Tract Infection Urine (UTI) Test Strips/2025062001(06/19/2027); LotFancy URS-3N Test Strip/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027); PALINOIA UTI-10 PARAMETER REAGENT STRIPS/2025042110(04-20-2027), 2025021001(02-20-2027); Vaunn Medical 8-in-1 Urinalysis Reagent Strip/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); JNW Direct 4-in-1 UTl Urinalysis Test Strips/30D25WC(04/29/2027), 02D25WC(04/01/2027), 30E25WC(05/29/2027), 10H24WC(07/10/2026); Urinify STRENGTH/202403103-6(01/03/2026), 202504103-6(01/01/2027), 202505103-6(06/01/2027), 202504103-3(01/01/2027), 202505103-3(06/01/2027); Urinify ESSENTIAL/202403104-6(01/03/2026), 202504104-6(01/01/2027), 202505104-6(06/01/2027), 202504104-3(01/01/2027), 202505104-3(06/01/2027); Urinify Urinary Tract Infection (UTI)/202501105-5(01/02/2027)91,366
Z-1258-2026The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test; Name/Lot(Expiration): The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips/2024032508(03/24/2026), 2024071602(07/15/2026), 2024102108(10/20/2026); URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein/2025043007(04/29/2027); Vivoo Ketone Test/2024013122(01/30/2026)32,500
Z-1259-2026LH One Step Ovulation Test Device (Urine); Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)1,000
Z-1260-2026Menopause Test Cassette (Urine); Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)1,000
Z-1261-2026S. Typhi/Para Typhi A Antigen; Name/Lot(Expiration): S. Typhi/Para Typhi A Antigen/GT-STA 20251601(05-2027)1,000
Z-1262-2026Male Fertility Sperm Test for Home Use (Cassette); Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027)1,000
Z-1263-2026Exploro Highly Sensitive Male Fertility / Sperm Concentration Test; Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)4,800
Z-1264-2026Vivoo pH Test; Name/Lot(Expiration): Vivoo pH Test/2024013121(01/30/2026)500
Z-1265-2026Vivoo Protein Test; Name/Lot(Expiration): Vivoo Protein Test/2024013122(01/30/2026)500
Z-1266-2026Vivoo Vaginal pH Test; Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026)3,000
Z-1267-2026Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test; Name/Lot(Expiration): Vivoo Sodium Test/2024013123(01/30/2026); Vivoo Vitamin C Test/2024013124(01/30/2026); Vivoo Hydration Test/2024013119(01/30/2026), 2025051519(05/14/2027)3,300

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of TX, GA, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia, Texas.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Nov 22, 202512. FDA classified it Class II: Feb 4, 202623. Published in FDA’s Enforcement Report: Feb 11, 2026320252026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where were these recalled sperm tests sold?

The distribution pattern indicates they were distributed nationwide in the states of TX, GA, and CA.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1262-2026 (November 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1262-2026 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA