The Recall Desk
Severity pendingFDA (Devices)·Z-1257-2026·Announced 2026-02-11

LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS;

Pending LLM rewrite. Source: FDA_DEVICE Z-1257-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

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)
Manufacturer
Changchun Wancheng Bio-Electron Co., Ltd.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)

Distribution

Distributed nationwide across the United States.

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