{
  "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-0111-2014",
      "product_description": "Single Site Curved Needed Driver    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.",
      "product_quantity": "504 devices 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 428088-12    All distribution from 3-15-13 to 7-19-13.  Batch/Lot #  S10130521  S10130405  S10130401  S10130405  S10130405  S10130521  S10130405  S10130405  S10130406  S10130406  S10130411  S10130411  S10130613  S10130405  S10130327  S10130327  S10130319  S10130319  S10130626  S10130703  S10130405  S10130319  S10130521  S10130613  S10130502  S10130405  S10130401  S10130406  S10130521  S10130613  S10130502  S10130406  S10130411  S10130405  S10130327  S10130412  S10130613  S10130314  S10130411  S10130327  S10130327  S10130411  S10130406  S10130613  S10130626  S10130412  S10130521  S10130405  S10130405  S10130314  S10130401  S10130411  S10130626  S10130703  S10130703  S10130703  S10130626  S10130613  S10130502  S10130401  S10130412  S10130406  Batch/Lot #  S10130412  S10130405  S10130412  S10130314  S10130319  S10130502  S10130613  S10130405  S10130314  S10130405  S10130405  S10130613  S10130709  S10130703  S10130314  S10130319  S10130319  S10130314  S10130412  S10130521  S10130626  S10130411  S10130405  S10130521  S10130405  S10130319  S10130319  S10130319  S10130405  S10130405  S10130405  S10130314  S10130314  S10130314  S10130314  S10130319  S10130319  S10130319  S10130319  S10130314  S10130314  S10130314  S10130405  S10130327  S10130327  S10130405  S10130405  S10130412  S10130405  S10130327  S10130406  S10130406  S10130406  S10130613  S10130502  S10130613  S10130502  S10130521  S10130502  S10130613  S10130411  S10130502  Batch/Lot #  S10130412  S10130521  S10130521  S10130521  S10130521  S10130613  S10130521  S10130405  S10130401  S10130405  S10130405  S10130613  S10130613  S10130703  S10130703  S10130319  S10130319  S10130626  S10130703  S10130405  S10130405  S10130405  S10130405  S10130521  S10130521  S10130405  S10130327  S10130406  S10130412  S10130412  S10130411  S10130401  S10130405  S10130521  S10130502  S10130406  S10130613  S10130411  S10130613  S10130613  S10130405  S10130401  S10130327  S10130405  S10130406  S10130405  S10130405  S10130405  S10130319  S10130319  S10130406  S10130406  S10130703  S10130613  S10130502  S10130412  S10130412  S10130406  S10130406  S10130521  S10130626  S10130405  S10130401  S10130412  S10130405  S10130405  S10130613  S10130502"
    }
  ]
}