{
  "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": "2026-04-22",
    "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": "66524",
      "recalling_firm": "Intuitive Surgical, Inc.",
      "address_1": "1266 Kifer Rd Bldg 100",
      "address_2": "N/A",
      "postal_code": "94086-5304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom.   .",
      "recall_number": "Z-0110-2014",
      "product_description": "Single Site Bipolar Maryland Forceps    Intuitive Surgical, Sunnyvale, CA. 94086    The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.",
      "product_quantity": "286 boxes ( 6 instruments per box)  for a total of 2,220 affected clinical product",
      "reason_for_recall": "A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.",
      "recall_initiation_date": "20131002",
      "center_classification_date": "20131029",
      "termination_date": "20140904",
      "report_date": "20131106",
      "code_info": "Model number 428080-04    All distribution from 3-15-13 to 7-19-13.  Batch/Lot #  S10130510  S10130325  S10130314  S10130314  S10130415  S10130426  S10130329  S10130228  S10130418  S10130304  S10130418  S10130325  S10130325  S10130408  S10130408  S10130510  S10130415  S10130304  S10130314  S10130415  S10130418  S10130228  S10130329  S10130329  S10130415  S10130426  S10130426  S10130426  S10130408  S10130325  S10130228  S10130325  S10130426  S10130426  S10130418  S10130325  S10130510  S10130408  S10130415  S10130408  S10130228  S10130304  S10130418  S10130415  S10130426  S10130314  S10130426  S10130418  S10130228  S10130228  S10130304  S10130415  S10130415  S10130418  S10130408  S10130329  S10130314  S10130228  S10130228  S10130314  S10130325  S10130415  S10130426  Batch/Lot #  S10130426  S10130418  S10130408  S10130325  S10130415  S10130415  S10130415  S10130418  S10130325  S10130325  S10130329  S10130325  S10130314  S10130329  S10130426  S10130314  S10130408  S10130329  S10130426  S10130426  S10130325  S10130415  S10130426  S10130426  S10130325  S10130325  S10130325  S10130329  S10130329  S10130408  S10130415  S10130408  S10130408  S10130415  S10130415  S10130418  S10130426  S10130415  S10130325  S10130408  S10130418"
    }
  ]
}