The Recall Desk

Hazard

Unauthorized Marketing 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
3
Most recent
2026-04-29

Of the 5 unauthorized marketing recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (60%) 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 marketing 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

  • SevereFDA (Devices)·Z-1844-2026·2026-04-29

    Medline medical device kits recalled for regulatory compliance rescission

    Medline Industries has recalled six medical device kits (arthrogram trays, angiography packs, and neuro packs) because their 510(k) regulatory clearances have been rescinded by the FDA.

    Product
    Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1695-2025·2025-05-07

    Quantum Informatics VIPER Physiological Monitor Recalled for Lack of FDA Clearance

    Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a patient monitoring software device, because it was marketed without required FDA clearance. The software is used in operating rooms to provide patient safety information.

    Product
    Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice soluti
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-1696-2025·2025-05-07

    Quantum Informatics VISION LIVE VUE Patient Monitor Recalled Without FDA Clearance

    Spectrum Medical Ltd. is recalling the Quantum Informatics VISION / LIVE VUE patient monitoring software because it was marketed without required FDA clearance or approval.

    Product
    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clini
    Category
    Medical Device
    Distribution
    38 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-0187-2022·2021-11-10

    COVENA PICC Sleeve Recalled for Unauthorized FDA Marketing

    Queen Comfort Products is recalling the COVENA PICC Sleeve, marketed without FDA clearance. Patients currently using the device should contact their healthcare provider immediately.

    Product
    COVENA PICC Sleeve
    Category
    Medical Device
    Distribution
    Distributed nationwide