{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "70758",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "311 Enterprise Dr",
      "address_2": "N/A",
      "postal_code": "08536-3344",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Distribution and to the countries of and to the countries of Greece, France, Italy, Spain, Switzerland, South America, Turkey and United Kingdom.",
      "recall_number": "Z-1452-2015",
      "product_description": "Integra¿ Flowable Wound Matrix   Size 3cc 1 unit/box  single use, sterile device Rx Only   Model Number FWD301 (US) & FDR301 (Non-US)    Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray:  - An empty plastic syringe with Luer-Lok\" tip  - A plastic syringe with Luer-Lok\" tip containing the Flowable Wound Matrix material  - A syringe-to-syringe Luer-Lok\" adapter / connector  - A flexible plastic tube (injector) with Luer-Lok\" connector  Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.",
      "product_quantity": "287 packages ( 179 US  108 OUS )",
      "reason_for_recall": "A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).",
      "recall_initiation_date": "20150313",
      "center_classification_date": "20150416",
      "termination_date": "20160413",
      "report_date": "20150422",
      "code_info": "Model Number FWD301 (US) & FDR301 (Non-US)      The following Lot Numbers on the packaged kits are affected:  -  305000293250, 305000293251, 305000298616 (foreign)    The syringes within the packaged kits are also Lot numbered.  For the packaged kit Lot Numbers above, the corresponding respective syringe Lot Numbers are:   -  10500028786, 105000288118, 105N00288965 (foreign)"
    }
  ]
}