The Recall Desk

Hazard

Unknown Performance recalls

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

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2023-11-01

Of the 13 unknown performance 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 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.

1–13 of 13

  • HighFDA (Devices)·Z-0056-2024·2023-11-01

    Ketone Test Strips Recalled for Lack of FDA Marketing Authorization

    Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.

    Product
    PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0059-2024·2023-11-01

    SARS-CoV-2 Antibody Test Recalled Due to Manufacturing Compliance Issues

    Universal Meditech Inc. is recalling the DiagnosUS SARS-CoV-2 Antibody Test because the devices were distributed without marketing authorization and the manufacturer cannot verify manufacturing compliance or post-market safety oversight.

    Product
    DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0068-2024·2023-11-01

    OMTMO Ovulation Test Strips Recalled for Unverified Manufacturing Quality

    Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.

    Product
    OMTMO One Step Ovulation (LH) Test Strips REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0061-2024·2023-11-01

    Unauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech

    Universal Meditech Inc. is recalling multiple diagnostic test kits distributed without FDA authorization. The firm is closing operations and cannot verify Quality System compliance or provide post-market support.

    Product
    Lem Fertility hCG Pregnancy Urine Test REF 100-12
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0042-2024·2023-11-01

    One Step Pregnancy Test Recalled for Unverified FDA Marketing Authorization

    Universal Meditech recalled 147,000 pregnancy tests lacking verified FDA clearance and quality documentation. The manufacturer is closing and cannot support post-market safety surveillance.

    Product
    One Step Pregnancy Test REF 100-01
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0055-2024·2023-11-01

    Pregnancy Test Kits Recalled Due to Unverified Manufacturing and Unauthorized Distribution

    Universal Meditech Inc. is recalling PrestiBio Rapid Detection Pregnancy Test Midstream kits (manufactured after March 2021) because the company distributed them without FDA authorization and cannot verify manufacturing compliance.

    Product
    PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0066-2024·2023-11-01

    Pregnancy Test Recalled Due to Quality Documentation Issues and Unauthorized Distribution

    Universal Meditech Inc. is recalling DiagnosUS Pregnancy Test Midstream kits (3,304 units) due to inability to verify marketing authorization and missing quality documentation. The company, which is closing, cannot fulfill post-market safety responsibilities.

    Product
    DiagnosUS Pregnancy Test Midstream REF 100-17
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0060-2024·2023-11-01

    Diagnostic Test Strips Recalled for Manufacturing Conformance and Documentation Issues

    Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.

    Product
    DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0065-2024·2023-11-01

    Pregnancy Test Cassettes Recalled for Unknown Performance Characteristics

    Universal Meditech Inc. recalls DiagnosUS hCG Pregnancy Test cassettes distributed in eight U.S. states due to lack of manufacturing documentation and unknown performance characteristics. The firm is going out of business.

    Product
    DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0047-2024·2023-11-01

    pH Test Strips Recalled for Unverified Manufacturing and Unknown Performance

    Universal Meditech Inc. is recalling HealthyWiser pH-Aware pH Test Strips because the manufacturer lacks documentation verifying manufacturing compliance and device performance. The company is ceasing operations and cannot fulfill post-market safety responsibilities.

    Product
    HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0062-2024·2023-11-01

    Universal Meditech diagnostic test strips recalled for unauthorized distribution

    Universal Meditech is recalling multiple diagnostic test strips distributed without FDA authorization. The company is closing and cannot provide documentation of manufacturing quality or post-market monitoring.

    Product
    Lem Fertility LH Ovulation Test (Strip) REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0050-2024·2023-11-01

    Pregnancy test strips recalled due to manufacturing documentation gaps

    Universal Meditech Inc. is recalling To Life hCG pregnancy test strips because the company is ceasing operations and cannot verify manufacturing compliance. The firm cannot provide documentation of manufacturing standards, storage conditions, or post-market safety monitoring.

    Product
    To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
    Category
    Medical Device
    Distribution
    8 states