{
  "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": "211378",
      "product_res_number": "Z-0784-2025",
      "event_date_initiated": "2024-11-21",
      "event_date_posted": "2024-12-30",
      "recall_status": "Open, Classified",
      "res_event_number": "95852",
      "product_code": "NWU",
      "product_description": "Medline custom medical procedure kits labeled as:  \n1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; \n2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; \n3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; \n4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; \n5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.",
      "code_info": "1) REF DYNJ58648B, UDI/DI 10193489624182 (EA) 40193489624183 (CS), Lot Numbers:  19BDB193; \n\n2) REF DYNJ58648C, UDI/DI 10193489688542 (EA) 40193489688543 (CS), Lot Numbers:  19EDD585, 19IDA770, 20AMA033, 20AMC750, 20EMB449; \n\n3) REF DYNJ66447, UDI/DI 10193489367379 (EA) 40193489367370 (CS), Lot Numbers:  20KMC595, 21AMB129; \n\n4) REF DYNJ58648D, UDI/DI 10195327212124 (EA) 40195327212125 (CS), Lot Numbers:  22KMD675, 23DMD129, 23HMG766, 23JMD938; \n\n5) REF DYNJ58648J, UDI/DI 10193489356793 (EA) 40193489356794 (CS), Lot Numbers:  20EBN856, 20JBG508, 20JBK503, 20JBT975, 20KBQ270, 21ABK829, 21EBP637, 21EBP646, 21JBO555, 21KBC098, 21KBV126, 21LBP144.",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email.  The notice explained the issue, potential risk to health, and requested that the affected product be quarantined.  Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.",
      "product_quantity": "1072 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of UAE, and Canada.",
      "openfda": {
        "device_name": "Endoscope Introducer Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "2029015",
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        "k_number": [
          "K933268",
          "K813332",
          "K874045"
        ]
      }
    }
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}