CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report

Menopause Test Cassette (Urine) recalled by Changchun Wancheng

Changchun Wancheng Bio-Electron Co is recalling Menopause Test Cassette (Urine), distributed nationwide in the US. The recall was initiated on 22 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesName/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)

Quantity recalled1,000

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1260-2026
FDA event ID: 97801
Recalling firm: Changchun Wancheng Bio-Electron Co, Changchun, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 22 Nov 2025
FDA classified: 4 Feb 2026
Reported: 11 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

22 Nov 2025	Recall initiated by company
4 Feb 2026	Classified by FDA	+74 days
11 Feb 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Menopause Test Cassette (Urine)

Where it was distributed

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

Nationwide California Georgia Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

10 other products · FDA event 97801

This product is part of a recall event; the main page for the event is Male Fertility Sperm Test for Home Use (Cassette) recalled.

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026	CLASS II	Male Fertility Sperm Test for Home Use (Cassette) recalled	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Exploro Highly Sensitive Male Fertility / Sperm Concentration Test recalled	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Vivoo Protein Test recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	LotFancy Urinary Tract Infection Urine (UTI) Test Strips recalled	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	S. Typhi/Para Typhi A Antigen recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	The Girlfriend Doctor Dr recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Vivoo pH Test recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Vivoo Sodium Test recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	LH One Step Ovulation Test Device (Urine) recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026	CLASS II	Vivoo Vaginal pH Test recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide

More recalls from Changchun Wancheng Bio-Electron Co

All 11

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Device	CLASS II	Vivoo Vaginal pH Test recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	LH One Step Ovulation Test Device (Urine) recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Vivoo Sodium Test recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	Vivoo pH Test recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide
11 Feb 2026Device	CLASS II	The Girlfriend Doctor Dr recalled by Changchun Wancheng	Changchun Wancheng Bio-Electron Co	Labeling Errors	Nationwide

Other Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide