{
  "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": 4
    }
  },
  "results": [
    {
      "cfres_id": "221304",
      "product_res_number": "Z-2788-2026",
      "event_date_initiated": "2026-06-11",
      "event_date_posted": "2026-07-23",
      "recall_status": "Open, Classified",
      "res_event_number": "99329",
      "product_code": "OEZ",
      "product_description": "Medline medical convenience kits labeled as:  \n1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B; \n2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.",
      "code_info": "Medline Kit SKU DYNJ910103B, UDI/DI 10198459346873 (each) 40198459346874 (case), Lot Number 25FBR237; \nMedline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25ABM761; \nMedline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25BBD107; \nMedline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBD534; \nMedline Kit SKU DYNJ910961A, UDI/DI 10198459213342 (each) 40198459213343 (case), Lot Number 25FBL772.",
      "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\n866-359-1704",
      "reason_for_recall": "Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.",
      "root_cause_description": "Process change control",
      "action": "Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees via email and USPS first class mail.  The notice explained the issue with the device, potential harms, and requested the following:  \nREQUIRED ACTION:\n1. Immediately check 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 the response form. Please list the quantity of affected product in inventory on the form. Even if there is no affected product in inventory, please complete and submit the form.  Website link: https://recalls.medline.com\n3. Upon receipt of the response form, the consignee account will receive over-labels to place on affected inventory, with instructions for the staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.  \nDistributors and those who transferred the affected product were directed to notify those to which the product was distributed or transferred.  \nFor contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "155 kits",
      "distribution_pattern": "US:  CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.",
      "openfda": {
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}