{
  "asOf": "2026-09-18",
  "snapshot": "2026-08-24",
  "unit": "Unique FDA product recall number; not an independent event, device, patient, or failure rate",
  "rows": 58785,
  "uniqueRecallNumbers": 58785,
  "rootCauseCategories": 44,
  "rootCauses": {
    "Other": 8928,
    "Device Design": 7621,
    "Under Investigation by firm": 6777,
    "Process control": 6494,
    "Nonconforming Material/Component": 5863,
    "Software design": 3449,
    "Packaging": 1663,
    "Component design/selection": 1602,
    "Packaging process control": 1454,
    "Process design": 1194,
    "Employee error": 1162,
    "No Marketing Application": 953,
    "Process change control": 904,
    "Error in labeling": 896,
    "Package design/selection": 848,
    "Labeling design": 844,
    "Material/Component Contamination": 695,
    "Unknown/Undetermined by firm": 647,
    "Equipment maintenance": 636,
    "Labeling Change Control": 594,
    "Labeling mix-ups": 569,
    "Component change control": 526,
    "Mixed-up of materials/components": 434,
    "Radiation Control for Health and Safety Act": 411,
    "Labeling False and Misleading": 392,
    "Pending": 344,
    "Use error": 323,
    "Storage": 306,
    "Packaging change control": 303,
    "Vendor change control": 288,
    "Environmental control": 249,
    "Software change control": 218,
    "Software Design Change": 213,
    "Incorrect or no expiration date": 179,
    "Software Manufacturing/Software Deployment": 137,
    "Software design (manufacturing process)": 126,
    "Reprocessing Controls": 113,
    "PMA": 109,
    "Manufacturing material removal": 98,
    "Software in the Use Environment": 82,
    "Release of Material/Component prior to receiving test results": 76,
    "Finished device change control": 48,
    "": 13,
    "Counterfeit": 4
  },
  "inputSha256": "0dd8a013c319b39a56f013c2c05ad8ad724129d3d8b31abc5c588ef207fe5cd0",
  "missingInitiationDate": 0,
  "invalidOrImplausibleInitiationDateCount": 21,
  "invalidOrImplausibleDateRecallNumbers": [
    "Z-1044-2013",
    "Z-1422-2013",
    "Z-1038-2013",
    "Z-0993-2014",
    "Z-0709-2014",
    "Z-0660-2013",
    "Z-0493-2014",
    "Z-1037-2013",
    "Z-1423-2013",
    "Z-1324-2013",
    "Z-0139-2014",
    "Z-1036-2013",
    "Z-1040-2013",
    "Z-0002-2014",
    "Z-1039-2013",
    "Z-1043-2013",
    "Z-0536-2014",
    "Z-0911-2011",
    "Z-1042-2013",
    "Z-1041-2013",
    "Z-1813-2013"
  ],
  "packagingNarrow": 3117,
  "packagingBroad": 4268,
  "nonspecificOrUnresolvedGrouping": {
    "labels": [
      "Other",
      "Under Investigation by firm",
      "Unknown/Undetermined by firm",
      "Pending",
      ""
    ],
    "records": 16709,
    "sharePercent": 28.4,
    "interpretation": "Analyst-defined grouping; Other does not necessarily mean an incomplete investigation."
  },
  "hypotheticalZeroFailureExample": {
    "n": 100,
    "observedFailures": 0,
    "oneSidedConfidence": 0.95,
    "upperBound": 0.029513049607039932,
    "assumptions": "Independent representative binomial observations; not a device acceptance criterion or a field harm estimate."
  },
  "scopedPricingExtract": {
    "source": "Pure Global Master Price List.xlsx; approved internal workbook checked September 18, 2026",
    "currency": "USD",
    "rows": [
      {
        "sheet": "USA",
        "row": 2,
        "service": "US Agent",
        "fee": "1000",
        "frequency": "Annual",
        "scope": "FDA fee-processing support, establishment registration and official-correspondent services; excludes submission compilation."
      },
      {
        "sheet": "USA",
        "row": 3,
        "service": "510(k) compilation and submission",
        "fee": "15000\u201320000",
        "frequency": "Per submission",
        "scope": "Expert confirmation of scope and pricing required."
      },
      {
        "sheet": "USA",
        "row": 5,
        "service": "Regulatory pathway",
        "fee": "5000",
        "frequency": "Per project",
        "scope": "Determines the correct regulatory route."
      },
      {
        "sheet": "USA",
        "row": 9,
        "service": "RAQA ad hoc support",
        "fee": "250",
        "frequency": "Per hour",
        "scope": "Ad hoc support; specific engagement to be agreed."
      }
    ],
    "iso14971SpecificPriceRows": 0,
    "note": "These figures do not quote risk-management-file creation; engineering evidence and scope require a specific agreement."
  }
}