{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lexington",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75827",
      "recalling_firm": "Tepha Incorporated",
      "address_1": "99 Hayden Ave Ste 360",
      "address_2": "N/A",
      "postal_code": "02421-7966",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide Distribution to IN, CA, FL, MI, NV, and MT",
      "recall_number": "Z-0948-2017",
      "product_description": "GalaSHAPE 3D; product code SH3D03, a medium size oval  GalaSHAPE\" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE\" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.",
      "product_quantity": "29",
      "reason_for_recall": "Endotoxin values from testing of retains slightly exceeded the established specification.",
      "recall_initiation_date": "20161121",
      "center_classification_date": "20170105",
      "termination_date": "20170105",
      "report_date": "20170111",
      "code_info": "Lot Number: 160294"
    }
  ]
}