{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Fremont",
      "address_1": "47900 Bayside Pkwy",
      "reason_for_recall": "The AXS Infinity LS Long Sheath Dilator  outer diameter (OD) specification was exceeded.",
      "address_2": "",
      "product_quantity": "15 units",
      "code_info": "Lot No. 20156091 ;UPN: GEN-10800-80-S2  UDI (01)07613327298253 (17)201130 (10) 20156091.",
      "center_classification_date": "20180928",
      "distribution_pattern": "Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.",
      "state": "CA",
      "product_description": "AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90)  Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.",
      "report_date": "20181010",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Neurovascular",
      "recall_number": "Z-3281-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80652",
      "more_code_info": "",
      "recall_initiation_date": "20180502",
      "postal_code": "94538-6515",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}