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

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

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

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

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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