{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "85558",
      "product_res_number": "Z-0181-2010",
      "event_date_initiated": "2009-09-27",
      "event_date_posted": "2009-11-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-03-31",
      "res_event_number": "53458",
      "product_code": "MGR",
      "pma_numbers": [
        "P950032"
      ],
      "product_description": "Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. \n\nIndicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.",
      "code_info": "Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009.  Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73.",
      "firm_fei_number": "1000148471",
      "recalling_firm": "Organogenesis, Inc.",
      "address_1": "150 Dan Road",
      "city": "Canton",
      "state": "MA",
      "postal_code": "02021-2820",
      "additional_info_contact": "Kristine Burke\n781-615-1818",
      "reason_for_recall": "Unit contaminated with Staphylococcus epidermidis",
      "root_cause_description": "Packaging process control",
      "action": "Organogenesis, Inc. initiated a recall notification dated September 28, 2009 via fax to Physicians asking for return of unused affected product. If the unit was  used, Physicians are advised to use standard wound care precautions to assure the safety of the patient.  Users were asked to acknowledge receipt by completing and returning the notification to the firm.\n\nFor further information, contact Organogenesis, Inc. at 1-888-432-5232.",
      "product_quantity": "60 units",
      "distribution_pattern": "Nationwide Distribution",
      "openfda": {
        "pma_number": [
          "P950032",
          "P900033",
          "P960007",
          "P000036",
          "P010016"
        ],
        "registration_number": [
          "2029275",
          "1121308",
          "3009882464",
          "1221816",
          "3003418325",
          "3008087383"
        ],
        "fei_number": [
          "1121308",
          "3009882464",
          "1000306431",
          "3003418325",
          "1000148471",
          "3008087383"
        ],
        "device_name": "Dressing, Wound And Burn, Interactive",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}