The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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36051–36075 of 40449

  • ModerateFDA (Devices)·Z-1370-2014·2014-04-16

    LumiQuick Barbiturate Strip Recalled for Unapproved Distribution

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

    Product
    Barbiturate Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1338-2014·2014-04-16

    LumiQuick Syphilis Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Syphilis Test Cards because they were shipped to locations without required FDA clearances.

    Product
    Syphilis Test Card Whole Blood(Serum) 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-1354-2014·2014-04-16

    LumiQuick Salmonella Typhi Test Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Salmonella typhi IgG/IgM Duo Tests because they were shipped to US locations without required FDA clearance.

    Product
    Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1410-2014·2014-04-16

    LumiQuick Troponin I Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to US locations without required FDA clearance.

    Product
    Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1367-2014·2014-04-16

    LumiQuick Drugs of Abuse Panel Test Device Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling its Drugs of Abuse Panel Test Device because it was shipped to locations without required FDA approvals.

    Product
    Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1378-2014·2014-04-16

    LumiQuick MDMA/Ecstasy Strip Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling MDMA/Ecstasy test strips because they were shipped to locations without required FDA regulatory clearance.

    Product
    MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1392-2014·2014-04-16

    LumiQuick Ketamine Strip Recalled for Unapproved US Distribution

    LumiQuick Diagnostics is recalling all lots of its Ketamine Strip because the products were shipped to US locations without required FDA clearance.

    Product
    Ketamine Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1395-2014·2014-04-16

    LumiQuick Buprenorphine Test Cards Recalled for Unapproved Distribution

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

    Product
    Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1373-2014·2014-04-16

    LumiQuick Benzodiazepine Test Card Recalled for Unauthorized Distribution

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

    Product
    Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1411-2014·2014-04-16

    LumiQuick Cardiac Panel Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Cardiac Panel Tests because they were shipped to locations without required FDA approvals.

    Product
    Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1374-2014·2014-04-16

    LumiQuick Cocaine Strip Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Cocaine Strips shipped to US locations without approved FDA applications.

    Product
    Cocaine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1341-2014·2014-04-16

    LumiQuick H. Pylori Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling H. Pylori Antigen Test Cards because they were shipped to locations without required FDA clearance.

    Product
    H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1396-2014·2014-04-16

    LumiQuick Oxycodone Strip Recalled for Unapproved Distribution

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

    Product
    Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1409-2014·2014-04-16

    LumiQuick Troponin I Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to locations without required FDA clearance.

    Product
    Troponin I 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-1389-2014·2014-04-16

    LumiQuick PCP Test Cards Recalled for Unauthorized Distribution

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

    Product
    PCP Test Card; 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-1352-2014·2014-04-16

    LumiQuick Malaria Pan Antigen Test Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Malaria pan Antigen Tests because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1353-2014·2014-04-16

    LumiQuick Salmonella Antigen Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Salmonella typhi/paratyphi Antigen Tests because they were shipped to locations without FDA approval.

    Product
    Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1449-2014·2014-04-16

    Roche Cobas c502 Analyzer Recall Due to Inactive Volume Check

    Roche Diagnostics is recalling 76 Cobas c502 clinical chemistry analyzers because the Initial Cassette Volume Check feature fails to activate when specific reagent packs are loaded.

    Product
    Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2014·2014-04-16

    LumiQuick Methadone Test Strips Recalled for Unapproved Distribution

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

    Product
    Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1345-2014·2014-04-16

    LumiQuick Adenovirus Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling all lots of the Adenovirus Antigen Test Card because they were shipped to locations without approved FDA applications.

    Product
    Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states