{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217344",
      "product_res_number": "Z-0886-2026",
      "event_date_initiated": "2025-10-27",
      "event_date_posted": "2025-12-05",
      "recall_status": "Open, Classified",
      "res_event_number": "97968",
      "product_code": "OEZ",
      "product_description": "MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C",
      "code_info": "UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081",
      "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 item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline Industries issued an URGENT MEDICAL DEVICE RECALL to its consignee on 10/27/2025 via email.  The notice explained the issue, potential risk, and requested the affected product be quarantined.  Once the firm receives the  response form, Medline will provide over-labels which are to be placed on kits that contain the recalled component and will state the affected component shall be removed and discarded from further use.  \nDistributors and those further distributing the affected product are directed to notify those to whom the product was transferred or distributed of the recall.  \nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "15 units",
      "distribution_pattern": "US Nationwide distribution in the state of CA.",
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}