{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216126",
      "product_res_number": "Z-0374-2026",
      "event_date_initiated": "2025-09-26",
      "event_date_posted": "2025-11-03",
      "recall_status": "Open, Classified",
      "res_event_number": "97623",
      "product_code": "HBF",
      "k_numbers": [
        "K183581"
      ],
      "product_description": "CODMAN Disposable Perforator 9mm. Cranial Perforator.",
      "code_info": "Model No. 261223; UDI: 10381780513605; Lot No. 5828553, 6264478, 6264481, 6264482, 7230672, 7230673, 7230674, 7230675, 7261971, 7268008, 7268009, 7268010, 7268011, 7268012, 7268013, 7268014, 7268015, 7268016, 7268017, 7268018, 7268019, 7282954, 7282955, 7293422, 7293423, 7293424, 7293425, 7293426, 7293427, 7293428, 7300667, 7300668, 7300669, 7300670, 7300672, 7300673, 7300674, 7371082, 7371083, 7379652, 7379922, 7379923, 7379924, 7379926, 7379928, 7379660, 7379925, 7379927, 7450559, 7450560, 7450561, 7450562, 7450563, 7450564, 7450565, 7450566, 7451273, 7451274, 7451275, 7451276, 7451277, 7451278, 7451279; Expiration Date: 2024-03-31 to 2029-07-31.",
      "firm_fei_number": "3003418325",
      "recalling_firm": "Integra LifeSciences Corp. (NeuroSciences)",
      "address_1": "1100 Campus Rd",
      "city": "Princeton",
      "state": "NJ",
      "postal_code": "08540-6650",
      "additional_info_contact": "Mary O'Neill\n1-609-275-0500",
      "reason_for_recall": "Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.",
      "root_cause_description": "Process change control",
      "action": "An URGENT: MEDICAL DEVICE RECALL notification dated 9/26/25 was mailed to consignees. \n\nCustomers with affected devices are to be immediately removed and quarantined. Customers are to send their completed Acknowledgement Form to FCA3@integralife.com or by fax at 1-609-750-4220. Forward the recall notification to those who use the product for their awareness. Integra Customer Service will reach out to consignees to facilitate product return.\n\nDistributors and Sales Representatives with affected devices are to remove product from further distribution. They are to send their completed Acknowledgement Form to FCA3@integralife.com or by fax at 1-609-750-4220. Distributors are to create an acknowledgement form from the distributor to their customers and provide them with a copy of the recall notification. Sales Representatives are to receive further directions from Integra Customer Service after their Acknowledgement Form has been received. \n\nConsignees with any questions are to call 1-800-654-2873 or email custsvcnj@integralife.com.",
      "product_quantity": "5,109 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.",
      "openfda": {
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          "K032970",
          "K791101",
          "K833266",
          "K875019",
          "K933894",
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          "K213228",
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          "K082637",
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        "fei_number": [
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        ],
        "device_name": "Drills, Burrs, Trephines & Accessories (Compound, Powered)",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4305",
        "device_class": "2"
      }
    }
  ]
}