FDA · Medical device recall

LotFancy Urinary Tract Infection Urine (UTI) Test Strips… and 10 more products

Feb. 11, 2026 Class II

Date: Feb. 11, 2026
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Ongoing
Filed by: Changchun Wancheng Bio-Electron Co., Ltd.
Reason: 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 pattern: US Nationwide distribution in the states of TX, GA, CA.

11 products in this recall

LotFancy Urinary Tract Infection Urine (UTI) Test Strips…

Product: LotFancy 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)
Quantity: 91,366
Codes and lots: 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)
Recall started: Nov. 22, 2025
Device type: Test, Urine Leukocyte
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1257-2026

The Girlfriend Doctor Dr…

Product: The 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
Quantity: 32,500
Codes and lots: 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)
Recall started: Nov. 22, 2025
Device type: Nitroprusside, Ketones (Urinary, Non-Quant.)
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1258-2026

LH One Step Ovulation Test Device (Urine)

Product: LH One Step Ovulation Test Device (Urine)
Quantity: 1,000
Codes and lots: Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)
Recall started: Nov. 22, 2025
Device type: Test, Luteinizing Hormone (Lh), Over The Counter
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1259-2026

Menopause Test Cassette (Urine)

Product: Menopause Test Cassette (Urine)
Quantity: 1,000
Codes and lots: Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)
Recall started: Nov. 22, 2025
Device type: Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1260-2026

S. Typhi/Para Typhi A Antigen

Product: S. Typhi/Para Typhi A Antigen
Quantity: 1,000
Codes and lots: Name/Lot(Expiration): S. Typhi/Para Typhi A Antigen/GT-STA 20251601(05-2027)
Recall started: Nov. 22, 2025
Device type: Antiserum, Typhus Fever
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1261-2026

Male Fertility Sperm Test for Home Use (Cassette)

Product: Male Fertility Sperm Test for Home Use (Cassette)
Quantity: 1,000
Codes and lots: Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027)
Recall started: Nov. 22, 2025
Device type: Material, Quality Control, Semen Analysis
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1262-2026

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

Product: Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Quantity: 4,800
Codes and lots: Name/Lot(Expiration): Exploro Highly Sensitive Male Fertility / Sperm Concentration Test/2025033101(03-30-2027), 2025080801(08-07-2027), 2025090844(09-07-2027)
Recall started: Nov. 22, 2025
Device type: Sperm, Antigen, Antiserum, Control
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1263-2026

Vivoo pH Test

Product: Vivoo pH Test
Quantity: 500
Codes and lots: Name/Lot(Expiration): Vivoo pH Test/2024013121(01/30/2026)
Recall started: Nov. 22, 2025
Device type: Dye-Indicator, Ph (Urinary, Non-Quantitative)
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1264-2026

Vivoo Protein Test

Product: Vivoo Protein Test
Quantity: 500
Codes and lots: Name/Lot(Expiration): Vivoo Protein Test/2024013122(01/30/2026)
Recall started: Nov. 22, 2025
Device type: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1265-2026

Vivoo Vaginal pH Test

Product: Vivoo Vaginal pH Test
Quantity: 3,000
Codes and lots: Name/Lot(Expiration): Vivoo Vaginal pH Test/2024032219(03/21/2026)
Recall started: Nov. 22, 2025
Device type: Paper, Obstetric Ph
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1266-2026

Vivoo Sodium Test…

Product: Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Quantity: 3,300
Codes and lots: 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)
Recall started: Nov. 22, 2025
Device type: Urinalysis Controls (Assayed And Unassayed)
Root cause (FDA): No Marketing Application
What the company told customers: Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com
Recall number: Z-1267-2026

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1257-2026, Z-1258-2026, Z-1259-2026, Z-1260-2026, Z-1261-2026, Z-1262-2026, Z-1263-2026, Z-1264-2026 and others. The agency record governs; check it and the company before acting.

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