The Recall Desk

Hazard

Unknown Performance Characteristics recalls

3 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2023-11-01

Of the 3 unknown performance characteristics recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unknown performance characteristics recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–3 of 3

  • HighFDA (Devices)·Z-0064-2024·2023-11-01

    FDA Recalls Pregnancy Test Cassettes Due to Unverified Manufacturing

    Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.

    Product
    DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0045-2024·2023-11-01

    UTI Test Strips Recalled for Lack of Quality Documentation and Compliance Verification

    Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.

    Product
    HealthyWiser UriTest" UTI Test Strips REF 900-UTI
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0049-2024·2023-11-01

    Pregnancy Test Recalled for Unverified Manufacturing Compliance and Firm Closure

    Universal Meditech Inc. is recalling the Am I Pregnant? One Step HCG Pregnancy Test because the company is going out of business and cannot verify manufacturing compliance or provide quality system documentation.

    Product
    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
    Category
    Medical Device
    Distribution
    8 states