{
  "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": [
    {
      "status": "Terminated",
      "city": "Sunnyvale",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78908",
      "recalling_firm": "Intuitive Surgical, Inc.",
      "address_1": "1266 Kifer Rd Bldg 101",
      "address_2": "N/A",
      "postal_code": "94086-5304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-0404-2018",
      "product_description": "daVinci X EndoWrist(R) Stapler 45, REF 470298    Product Usage:  The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with the same staple line or tissue buttressing material (natural synthetic).",
      "product_quantity": "60 units",
      "reason_for_recall": "Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.",
      "recall_initiation_date": "20170919",
      "center_classification_date": "20180123",
      "termination_date": "20240130",
      "report_date": "20180131",
      "code_info": "UDI 00886874112427:  Serial Numbers:  S10170630, S11170705, S10170707, S10170731"
    }
  ]
}