{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220250",
      "product_res_number": "Z-2404-2026",
      "event_date_initiated": "2026-04-29",
      "event_date_posted": "2026-06-11",
      "recall_status": "Open, Classified",
      "res_event_number": "98941",
      "product_code": "LGW",
      "pma_numbers": [
        "P030017"
      ],
      "product_description": "Boston Scientific Model SC-4318, Clik X Anchor\nREF: M365SC43180",
      "code_info": "GTIN: 08714729905318/Lot # 35107836",
      "firm_fei_number": "3006630150",
      "recalling_firm": "Boston Scientific Neuromodulation Corporation",
      "address_1": "25155 Rye Canyon Loop",
      "city": "Valencia",
      "state": "CA",
      "postal_code": "91355-5004",
      "additional_info_contact": "Renee Archie\n661-949-4000",
      "reason_for_recall": "Sterile anchors my lack sterility assurance.",
      "root_cause_description": "Packaging process control",
      "action": "On April 29, 2026, Boston Scientific issued a Urgent Medical Device Recall via mail. Boston Scientific ask consignees to take the following actions: \n\n\n1. Do NOT use Affected Product (Table 1), remove affected product from your facility s inventory, and segregate the units in a secure place until they can be returned to Boston Scientific.\n2 Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device.\n3. Forward this notice to any healthcare professional from your organization for awareness and to any organization to which affected devices have been transferred.\n4.  Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions.\n5. Return Affected Product.",
      "product_quantity": "43 units",
      "distribution_pattern": "US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.",
      "openfda": {
        "device_name": "Stimulator, Spinal-Cord, Totally Implanted For Pain Relief",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P130028",
          "P210037",
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          "P800040",
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