{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 11
    }
  },
  "results": [
    {
      "cfres_id": "221698",
      "product_res_number": "Z-3019-2026",
      "event_date_initiated": "2026-07-10",
      "event_date_posted": "2026-08-26",
      "recall_status": "Open, Classified",
      "res_event_number": "99507",
      "product_code": "OES",
      "product_description": "Medline convenience kits labeled as:  \n1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; \n2) FEVAR, Medline Kit SKU DYNJ910295D.",
      "code_info": "1) Medline Kit SKU DYNJ909393A, UDI/DI  10195327613945 (each) 40195327613946 (case) Lot Number 25ILA297; \n2) Medline Kit SKU DYNJ910295D, UDI/DI 10198459586477 (each) 40198459586478 (case), Lot Number 26CBT178.",
      "firm_fei_number": "1417592",
      "recalling_firm": "Medline Industries, LP",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866359-633-5463",
      "reason_for_recall": "Kits contain a potentially contaminated component which were recalled by the manufacturer",
      "root_cause_description": "Process change control",
      "action": "Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/1/2026 via USPS and email.  The notice explained the issue, potential hazard, and requested the following:  \n\"REQUIRED ACTION:  \n1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.  \n2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form.  \nWebsite link: https://recalls.medline.com Recall Reference #: R-26-120-FG-FGX2  \nRecall Code:   \n3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.  \n4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers  quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.\"  \nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "71 kits",
      "distribution_pattern": "US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.",
      "openfda": {
        "registration_number": [
          "1643817",
          "3015173212",
          "3004911384",
          "3008513424",
          "1928237",
          "9680794",
          "9616099",
          "1423395",
          "3011144486",
          "1423537",
          "3010532612",
          "3035642068",
          "1422634",
          "3004122598",
          "9616088",
          "1061124",
          "1047429",
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          "3011137372",
          "3009888344",
          "3045816907",
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          "1824619",
          "3004519921",
          "3005012805",
          "3007329020",
          "3005595283",
          "3004111573"
        ],
        "fei_number": [
          "1643817",
          "3015173212",
          "3004911384",
          "3008513424",
          "1928237",
          "3000717925",
          "1000160458",
          "3005747797",
          "3011144486",
          "3010532612",
          "3035642068",
          "3004122598",
          "1047429",
          "3045816902",
          "3009888344",
          "1000512168",
          "3045816907",
          "1030451",
          "3002902735",
          "3003528016",
          "1018470",
          "1016427",
          "1824619",
          "3003737899",
          "3005012805",
          "3007329020",
          "3005595283",
          "3005846326",
          "1000514656",
          "3001236905",
          "3004111573"
        ],
        "device_name": "Cardiac Catheterization Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}