{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "175718",
      "product_res_number": "Z-2358-2019",
      "event_date_initiated": "2019-08-09",
      "event_date_created": "2019-08-23",
      "recall_status": "Open, Classified",
      "res_event_number": "83551",
      "product_code": "EYN",
      "product_description": "Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303.  Sterile Piston Irrigation Syringe Tray with Saline",
      "code_info": "Lot Number 19CAB954",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries Inc",
      "address_1": "Three Lakes Drive",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093",
      "additional_info_contact": "Benjamin Gora\n866-359-1704",
      "reason_for_recall": "Samples in the identified lot were found to have incomplete or open packaging seals.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Consignees were notified via first class mail on August 9, 2019.  The letter requested the following:  \n1.\tImmediately check your stock for item number DYNC2303 and the affected lot number, 19CAB954.  Quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form.  \n2.\tPlease return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form as indicated. \n\nWhen we receive your completed destruction form your account will be issued a credit, if applicable.\n\n3.\tIf you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.",
      "product_quantity": "11962 trays",
      "distribution_pattern": "US nationwide distribution",
      "openfda": {
        "k_number": [
          "K923939",
          "K760047",
          "K781748",
          "K790607",
          "K791020",
          "K781918",
          "K900737",
          "K801783",
          "K900736",
          "K923938",
          "K923941",
          "K923940",
          "K792082",
          "K944882",
          "K900148"
        ],
        "registration_number": [
          "1928237",
          "3045816902",
          "1057358",
          "1319639",
          "3004122598",
          "3005012805"
        ],
        "fei_number": [
          "1000208608",
          "1928237",
          "3045816902",
          "1000138054",
          "3004122598",
          "3005012805"
        ],
        "device_name": "Tray, Irrigation, Sterile",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5980",
        "device_class": "2"
      }
    }
  ]
}