The Recall Desk

Hazard

Unauthorized Use recalls

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

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2024-06-19

Of the 5 unauthorized use recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) 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 unauthorized use 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.

1–5 of 5

  • HighFDA (Devices)·Z-2034-2024·2024-06-19

    Streptococcal A Rapid Test Kits Recalled for Unauthorized At-Home Distribution

    Wondfo USA has recalled Streptococcal A rapid test kits that are being sold for unauthorized at-home and direct-to-consumer use. The kits should not be used outside professional healthcare settings.

    Product
    Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2022·2022-04-27

    Matrix COVID-19 Test Kits Recalled for Unauthorized Home Sample Collection

    Matrix Medical Network is recalling 3,226 At-Home COVID-19 Test kits distributed across 24 U.S. states because the tests were not authorized by the FDA for home sample collection.

    Product
    Matrix Clinical Solution At-Home COVID-19 Test
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-0680-2022·2022-03-09

    Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use

    Celltrion USA recalled COVID-19 rapid test kits (DiaTrust) in a Class I action. The kits are labeled for research use only, but the firm assured distributors they could be used for clinical diagnosis, which is not authorized.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1921-2021·2021-06-30

    Ultrasonic Transducer Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing is recalling 33,250 ultrasonic transducer probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1127-2021·2021-02-24

    Sky Medical SARS-CoV-2 Rapid Test Kits Recalled for Lack of Emergency Use Authorization

    Sky Medical Supplies and Equipments LLC is recalling 10,000 SARS-CoV-2 rapid test kits distributed in Florida and Peru because they were sold without FDA Emergency Use Authorization.

    Product
    AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
    Category
    Medical Device
    Distribution
    Distributed nationwide