The Recall Desk

Hazard

Regulatory Non Compliance recalls

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

What the numbers show

Total
536
Critical
0
Severe
56
Most recent
2026-07-01

Of the 536 regulatory non compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 56 (10%) 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 regulatory non compliance 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.

451–475 of 536

  • ModerateFDA (Devices)·Z-1404-2014·2014-04-16

    LumiQuick Fentanyl Test Card Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling Fentanyl Test Cards because they were shipped to US locations without approved FDA applications.

    Product
    Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1384-2014·2014-04-16

    LumiQuick Morphine Strip Recalled for Unapproved Distribution in US

    LumiQuick Diagnostics is recalling Morphine Strip (300) products distributed in California, Florida, New Jersey, Texas, and New York because they were shipped to locations without approved applications for PMA, IDE, or 510(k) clearance.

    Product
    Morphine Strip (300); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1340-2014·2014-04-16

    LumiQuick Dengue IgG/IgM Tests Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling all lots of its Dengue IgG/IgM tests because they were shipped to US locations without required FDA clearance.

    Product
    Dengue IgG/IgM; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1348-2014·2014-04-16

    LumiQuick H. Pylori Test Cards Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics is recalling H. Pylori Ab Test Cards because they were shipped to locations without approved FDA applications.

    Product
    H. Pylori Ab Test Card-Serum; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1351-2014·2014-04-16

    LumiQuick Malaria pf Antigen Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to US locations without required FDA regulatory clearance.

    Product
    Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1381-2014·2014-04-16

    LumiQuick Methadone Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Methadone Test Cards because they were shipped to locations without approved FDA applications or clearance.

    Product
    Methadone Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1357-2014·2014-04-16

    LumiQuick Malaria Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics Inc. is recalling Malaria pf/pan Antigen Test Cards because they were shipped to locations without approved FDA applications or clearance.

    Product
    Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1358-2014·2014-04-16

    LumiQuick Dengue NS1 Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling all lots of the Dengue NS1 Antigen Test Card because the products were shipped to US locations without approved regulatory clearance.

    Product
    Dengue NS1 Antigen Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1368-2014·2014-04-16

    LumiQuick Amphetamine Strip Recalled for Unapproved US Distribution

    LumiQuick Diagnostics is recalling Amphetamine Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Amphetamine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1343-2014·2014-04-16

    LumiQuick Salmonella typhi Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Salmonella typhi Antigen Test Cards because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1413-2014·2014-04-16

    LumiQuick Myoglobin Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Myoglobin Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1337-2014·2014-04-16

    LumiQuick Syphilis Test Strips Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling all lots of Syphilis Test Strips (Serum) because they were shipped to locations without approved FDA clearance.

    Product
    Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1376-2014·2014-04-16

    LumiQuick EDDP Strip Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling EDDP Strips because they were shipped to US locations without required FDA clearance.

    Product
    EDDP Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1364-2014·2014-04-16

    LumiQuick Saliva Alcohol Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling all lots of its Saliva Alcohol Test (Catalog 74001) because the products were shipped to US locations without approved regulatory clearance.

    Product
    Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1385-2014·2014-04-16

    LumiQuick Morphine Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Morphine Test Cards because they were shipped to US locations without required FDA approvals.

    Product
    Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1414-2014·2014-04-16

    LumiQuick Myoglobin Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Myoglobin Test Cards because they were shipped to locations without FDA clearance.

    Product
    Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1412-2014·2014-04-16

    LumiQuick Cardiac Panel Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics is recalling Cardiac Panel Test Cards because they were shipped to locations without approved regulatory clearance.

    Product
    Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1406-2014·2014-04-16

    LumiQuick Clonazepam Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Clonazepam Test Cards because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1390-2014·2014-04-16

    LumiQuick THC Strip Recalled for Unauthorized Distribution in US

    LumiQuick Diagnostics Inc. is recalling all lots of THC Strip (Catalog 74035) because they were shipped to US locations without required FDA clearance.

    Product
    THC Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1400-2014·2014-04-16

    LumiQuick Propoxyphene Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Propoxyphene Test Strips because they were shipped to US locations without required FDA clearance.

    Product
    Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1346-2014·2014-04-16

    LumiQuick Adeno/Rota Combo Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics Inc. is recalling Adeno/Rota Combo Test Cards because they were shipped to US locations without required FDA regulatory approvals.

    Product
    Adeno/Rota Combo Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states