The Recall Desk

Hazard

Unverified Performance recalls

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

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2023-11-01

Of the 9 unverified 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 unverified 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.

1–9 of 9

  • HighFDA (Devices)·Z-0067-2024·2023-11-01

    DiagnosUS Ovulation Predictor test recalled due to unverified manufacturing documentation

    Universal Meditech Inc. is recalling DiagnosUS Ovulation Predictor Midstream devices due to lack of FDA marketing authorization and inability to verify manufacturing compliance. The manufacturer is ceasing operations.

    Product
    DiagnosUS Ovulation Predictor Midstream REF 200-17
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0057-2024·2023-11-01

    PrestiBio Urinalysis Test Strips Recalled for Unverified Manufacturing

    Universal Meditech Inc. is recalling PrestiBio URINALASYS TEST STRIP 10 PARAMETERS due to missing manufacturing documentation and unverified device performance. The manufacturer is ceasing operations and cannot demonstrate the devices meet quality standards.

    Product
    PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0048-2024·2023-11-01

    Pregnancy Test Cassettes Recalled for Unverified Performance and Authorization

    Universal Meditech Inc. is recalling DeTec hCG pregnancy test cassettes due to unverified marketing authorization and missing manufacturing documentation. Device performance characteristics cannot be confirmed.

    Product
    DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0058-2024·2023-11-01

    FDA Recalls Ovulation Test Strips for Unverified Manufacturing and Documentation

    FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.

    Product
    DiagnosUS One Step LH Ovulation Test Strip REF 200-07
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0063-2024·2023-11-01

    Pregnancy test strips recalled for lack of FDA authorization and quality documentation

    Universal Meditech Inc. recalled DiagnosUS hCG pregnancy test strips because the company distributed them without FDA marketing authorization and cannot provide manufacturing compliance documentation. The firm is ceasing operations.

    Product
    DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1420-2021·2021-04-21

    Krishe Disposable Sampling Tubes Recalled for Missing Verification Data

    Krishe Inc is recalling 1.7 million disposable sampling tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1423-2021·2021-04-21

    Krishe Dasky Disposable Sampling Tubes Recalled for Missing Validation Data

    Krishe Inc is recalling Dasky Disposable Sampling Tubes because verification and validation data for the virus transport medium was not provided to the FDA prior to sale.

    Product
    Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R
    Category
    Medical Device
    Distribution
    4 states