{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "197366",
      "product_res_number": "Z-0909-2023",
      "event_date_initiated": "2022-12-02",
      "event_date_posted": "2023-01-06",
      "recall_status": "Open, Classified",
      "res_event_number": "91280",
      "product_code": "HBA",
      "k_numbers": [
        "K193346"
      ],
      "product_description": "Codman Surgical Patties, Part number 801400; SURG PATXRAY\n1/2X1/2-200; Lot 6396457",
      "code_info": "UDI-DI 10381780514961\nLot Number: 6396457\nExpiration date 06/30/2027",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp.",
      "address_1": "1100 Campus Rd",
      "city": "Princeton",
      "state": "NJ",
      "postal_code": "08540-6650",
      "additional_info_contact": "Lacey Gigante\n609-212-9004",
      "reason_for_recall": "Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.",
      "root_cause_description": "Process control",
      "action": "On December 2, 2022, the firm notified customers via \"URGENT VOLUNTARY MEDICAL DEVICE RECALL\" letters.\n\nCustomers were instructed to immediately remove units of affected product from service. Customers should complete the Acknowledgement Form and return to the recalling company. Once received, Customer Service will contact the customer to aid them in returning the affected product.\n\nShould you have any questions regarding these instructions, please contact Customer Service:\nMonday to Friday 8:00 AM   8:00 PM EST\nUSA: 1-800-654-2873: email: custsvcnj@integralife.com",
      "product_quantity": "168 US; 3 OUS",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN,  KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.",
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          "K962807",
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          "K844594",
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          "K014268",
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          "K020736",
          "K062406",
          "K993019",
          "K031008",
          "K970328",
          "K880402",
          "K112598",
          "K891993",
          "K973083",
          "K770894"
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        "fei_number": [
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          "1048735",
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        ],
        "device_name": "Neurosurgical Paddie",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4700",
        "device_class": "2"
      }
    }
  ]
}