{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "67037",
      "product_res_number": "Z-0675-2008",
      "event_date_initiated": "2007-12-26",
      "event_date_posted": "2008-01-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-05-15",
      "res_event_number": "46250",
      "product_code": "MGR",
      "pma_numbers": [
        "P950032"
      ],
      "product_description": "Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021",
      "code_info": "Lot Numbers: GS0711.20.01.2A and GS0711.22.01.2A",
      "firm_fei_number": "1000148471",
      "recalling_firm": "Organogenesis, Inc.",
      "address_1": "150 Dan Road",
      "city": "Canton",
      "state": "MA",
      "postal_code": "02021-2820",
      "additional_info_contact": "Patrick Bilbo\n781-575-0775",
      "reason_for_recall": "Contamination:  Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis.  Preliminary tests show a gram negative rod (bacillus) organism.",
      "root_cause_description": "Material/Component Contamination",
      "action": "On 12/26/07, Organogenesis began to telephone the consignees to inform them of the recall. The firm sent a follow-up fax on 12/31/07 to all treating physicians who applied the product requesting patient status information.  The Dear Doctor letter, dated December 27, 2007, was titled, \"Subject: Potential contaminated Apligraf Units manufactured by Organogenesis, Inc.\"  Consignees were instructed to return unused product, and monitor patients who received the Apligraf for adverse events.",
      "product_quantity": "177 units",
      "distribution_pattern": "Nationwide Distribution.",
      "openfda": {
        "pma_number": [
          "P900033",
          "P960007",
          "P950032",
          "P010016",
          "P000036"
        ],
        "registration_number": [
          "1221816",
          "3003418325",
          "3009882464",
          "3008087383",
          "2029275",
          "1121308"
        ],
        "fei_number": [
          "1000306431",
          "1000148471",
          "3003418325",
          "3009882464",
          "3008087383",
          "1121308"
        ],
        "device_name": "Dressing, Wound And Burn, Interactive",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}