Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 11, 2026
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)
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 f…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Changchun Wancheng Bio-Electron Co., Ltd. recalled LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAG… - a moderate-severity action.
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAG… was recalled by Changchun Wancheng Bio-Electron Co., Ltd. in February 11, 2026. Reason: Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before…. Check the official notice for the remedy. Verify recall #Z-1257-2026 with the FDA Devices before acting.
The recall
Changchun Wancheng Bio-Electron Co., Ltd. issued this moderate-severity FDA Devices recall-Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before….
- Moderate
- severity level
- 91K units
- affected scope
- Class II
- classification
- February 11, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1257-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1257-2026) was formally reported on February 11, 2026, with the manufacturer initiating the action on November 22, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Changchun Wancheng Bio-Electron Co., Ltd. is listed as the recalling firm, operating out of Changchun, N/A. Federal records list the affected scope as 91,366.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of TX, GA, CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
91,366
Related Recalls
6
3 from same agency
Product description
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)
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1257-2026 |
| Date reported | February 11, 2026 |
| Date initiated | November 22, 2025 |
| Recalling firm | Changchun Wancheng Bio-Electron Co., Ltd. |
| Firm location | Changchun, N/A |
| Affected scope | 91,366 |
| Distribution | US Nationwide distribution in the states of TX, GA, CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1257-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Changchun Wancheng Bio-Electron Co., Ltd.. Units affected: 91,366.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1257-2026.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of TX, GA, CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1257-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 11, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.