{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-08"
  },
  "results": [
    {
      "term": "Device Design",
      "count": 1192
    },
    {
      "term": "Other",
      "count": 1079
    },
    {
      "term": "Nonconforming Material/Component",
      "count": 856
    },
    {
      "term": "Under Investigation by firm",
      "count": 846
    },
    {
      "term": "Process control",
      "count": 825
    },
    {
      "term": "Software design",
      "count": 806
    },
    {
      "term": "Package design/selection",
      "count": 333
    },
    {
      "term": "Packaging process control",
      "count": 204
    },
    {
      "term": "Employee error",
      "count": 203
    },
    {
      "term": "Radiation Control for Health and Safety Act",
      "count": 202
    },
    {
      "term": "Process change control",
      "count": 192
    },
    {
      "term": "Packaging",
      "count": 176
    },
    {
      "term": "Component design/selection",
      "count": 141
    },
    {
      "term": "Process design",
      "count": 114
    },
    {
      "term": "Labeling design",
      "count": 102
    },
    {
      "term": "Error in labeling",
      "count": 87
    },
    {
      "term": "Labeling Change Control",
      "count": 87
    },
    {
      "term": "Labeling mix-ups",
      "count": 83
    },
    {
      "term": "Unknown/Undetermined by firm",
      "count": 73
    },
    {
      "term": "Equipment maintenance",
      "count": 65
    },
    {
      "term": "Mixed-up of materials/components",
      "count": 60
    },
    {
      "term": "Component change control",
      "count": 57
    },
    {
      "term": "Material/Component Contamination",
      "count": 51
    },
    {
      "term": "Software change control",
      "count": 43
    },
    {
      "term": "Labeling False and Misleading",
      "count": 40
    },
    {
      "term": "Software Design Change",
      "count": 38
    },
    {
      "term": "No Marketing Application",
      "count": 34
    },
    {
      "term": "Use error",
      "count": 34
    },
    {
      "term": "Software design (manufacturing process)",
      "count": 28
    },
    {
      "term": "Software in the Use Environment",
      "count": 26
    },
    {
      "term": "Incorrect or no expiration date",
      "count": 25
    },
    {
      "term": "Pending",
      "count": 24
    },
    {
      "term": "Software Manufacturing/Software Deployment",
      "count": 21
    },
    {
      "term": "PMA",
      "count": 18
    },
    {
      "term": "Storage",
      "count": 18
    },
    {
      "term": "Environmental control",
      "count": 16
    },
    {
      "term": "Vendor change control",
      "count": 13
    },
    {
      "term": "Packaging change control",
      "count": 10
    },
    {
      "term": "Release of Material/Component prior to receiving test results",
      "count": 7
    },
    {
      "term": "Finished device change control",
      "count": 6
    },
    {
      "term": "Manufacturing material removal",
      "count": 4
    },
    {
      "term": "Reprocessing Controls",
      "count": 2
    }
  ]
}