openFDA medical-device recall enforcement by firm/state/classification/date API

Queries openFDA DEVICE enforcement reports by firm, state, classification and/or date, normalized with Class->severity. Answers 'what Class I device recalls are out there?', 'has <manufacturer> recalled a device?'.

Price$0.01per request

MethodPOST

Route/v1/gov/fda-device-recalls

StatusLive

MIME typeapplication/json

Rate limit60/minute

Cache3600s public

govrecallsfdaopenfdamedical-deviceenforcementseverity

API URLhttps://x402.hexl.dev/v1/gov/fda-device-recalls

Integration docs

Example request

{
  "classification": "Class I",
  "limit": 2
}

Example response

{
  "query": "Class I",
  "totalRecalls": 2,
  "bySource": {
    "FDA": 2
  },
  "bySeverity": {
    "critical": 2,
    "high": 0,
    "moderate": 0,
    "low": 0,
    "unknown": 0
  },
  "aggregateRiskScore": 90,
  "aggregateRiskClass": "critical",
  "worstRecall": {
    "source": "FDA",
    "recallId": "Z-2372-2023",
    "date": "2023-06-28",
    "title": "MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray    REF: 8888102004HP",
    "firm": "Covidien LP",
    "productType": "devices",
    "hazard": "Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to  full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus",
    "remedy": null,
    "units": "685 units",
    "status": "Ongoing",
    "severityScore": 90,
    "severityClass": "critical",
    "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2372-2023"
  },
  "totalMatching": 3500,
  "recalls": [
    {
      "source": "FDA",
      "recallId": "Z-2372-2023",
      "date": "2023-06-28",
      "title": "MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray    REF: 8888102004HP",
      "firm": "Covidien LP",
      "productType": "devices",
      "hazard": "Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to  full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus",
      "remedy": null,
      "units": "685 units",
      "status": "Ongoing",
      "severityScore": 90,
      "severityClass": "critical",
      "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2372-2023"
    },
    {
      "source": "FDA",
      "recallId": "Z-0882-2023",
      "date": "2022-12-07",
      "title": "Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU10",
      "firm": "Philips Respironics, Inc.",
      "productType": "devices",
      "hazard": "The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.",
      "remedy": null,
      "units": "20,807",
      "status": "Ongoing",
      "severityScore": 90,
      "severityClass": "critical",
      "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0882-2023"
    }
  ]
}

Input schema

{
  "type": "object",
  "properties": {
    "firm": {
      "type": "string",
      "description": "Recalling firm name."
    },
    "state": {
      "type": "string",
      "description": "Two-letter US state of the firm."
    },
    "classification": {
      "type": "string",
      "description": "'Class I', 'Class II', or 'Class III'."
    },
    "since": {
      "type": "string",
      "description": "Earliest report date, YYYY-MM-DD."
    },
    "limit": {
      "type": "number",
      "description": "Max recalls (1-50, default 20)."
    }
  }
}

Output schema

{
  "type": "object",
  "additionalProperties": true
}