{
  "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": [
    {
      "country": "United States",
      "city": "San Jose",
      "address_1": "128 Bayview Drive",
      "reason_for_recall": "Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has  been identified as a compound of iron and chlorine.",
      "address_2": "",
      "product_quantity": "515 US, 315 International (all packaging configurations)",
      "code_info": "Model number FP-45616 and FP45173",
      "center_classification_date": "20131118",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide in the countries of:  Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.",
      "state": "CA",
      "product_description": "ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit  FP -23267):  and  ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable Kit, 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267).  RX.    Product Usage:  Skin Tensioner is applied to patient\u0019s scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.",
      "report_date": "20131127",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Restoration Robotics",
      "recall_number": "Z-0354-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66558",
      "termination_date": "20131210",
      "more_code_info": "",
      "recall_initiation_date": "20131013",
      "postal_code": "95134",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}