{
  "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": "210197",
      "product_res_number": "Z-0175-2025",
      "event_date_initiated": "2024-09-04",
      "event_date_posted": "2024-10-23",
      "recall_status": "Open, Classified",
      "res_event_number": "95415",
      "product_code": "OHD",
      "product_description": "Medline brand medical procedure convenience kits, labeled as:  \na) LITHOTOMY PACK, REF DYNJ24362C; \nb) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; \nc) GYN ANCILARY PACK, REF DYNJ84509; \nd) GYN LITHOTOMY MINOR, REF DYNJ907707",
      "code_info": "a) REF DYNJ24362C, UDI/DI 40889942830054 (each), 10889942830053 (case), Lot Numbers:  24ABG207; \nb) REF DYNJ46774B, UDI/DI 40889942582748 (each), 10889942582747 (case), Lot Numbers:  23LBN531; \nc) REF DYNJ84509, UDI/DI 40195327372881 (each), 10195327372880 (case), Lot Numbers:  23LBL712; \nd) REF DYNJ907707, UDI/DI 40193489848978 (each), 10193489848977 (case), Lot Numbers:  24ABR224",
      "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": "Karin Johnson\n866-359-1704",
      "reason_for_recall": "It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS.  The notice explained the issue, hazard, and requested the destruction of the affected product.  Distributors were directed to notify their consignees.",
      "product_quantity": "197 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
      "openfda": {
        "registration_number": [
          "1423537",
          "1423395",
          "3009888344",
          "3005012805",
          "1047429",
          "1000121056",
          "1055236",
          "1061124",
          "2124215",
          "1043214",
          "1054241",
          "1643817",
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          "2029015",
          "2320762",
          "3045816907",
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          "1928237",
          "9616088",
          "3014925393",
          "3004911384",
          "3004111573",
          "3007329020"
        ],
        "fei_number": [
          "3009888344",
          "3005012805",
          "1000160458",
          "3000717925",
          "3002902735",
          "1047429",
          "1000121056",
          "3001236905",
          "2124215",
          "1043214",
          "1000112968",
          "1643817",
          "3015173212",
          "1030451",
          "3004122598",
          "3003040625",
          "3005099803",
          "1000512168",
          "1000112877",
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          "3005595283",
          "3035642068",
          "3045816902",
          "3004859928",
          "1928237",
          "3014925393",
          "3004911384",
          "3004111573",
          "3007329020"
        ],
        "device_name": "Gynecological Laparoscopic Kit",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.1720",
        "device_class": "2"
      }
    }
  ]
}