{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "217875",
      "product_res_number": "Z-1085-2026",
      "event_date_initiated": "2025-12-16",
      "event_date_posted": "2026-01-14",
      "recall_status": "Open, Classified",
      "res_event_number": "98197",
      "product_code": "OEZ",
      "product_description": "Medline medical procedure convenience kits labeled as:  \n1) THORACIC ROBOTICS, REF DYNJ908777B; \n2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359",
      "code_info": "1) UDI/DI 10198459269196 (EA) 40198459269197 (CS), Lot Number 25EBD732; \n2) UDI/DI 10198459326318 (EA) 40198459326319 (CS), Lot Number 25FBA103.",
      "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\n800-359-1704",
      "reason_for_recall": "Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/16/2025 via email and USPS first class mail.  The notice explained the issue, potential risk, and requested the following:  \n\"1.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 quantityof affected product you have in inventory on the form. Even if you do not have any affected productin inventory, please complete and submit the form.\nWebsite link: https://recalls.medline.comRecall Reference #: R-25-145-FGX5\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.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.\"",
      "product_quantity": "96 units",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "Cardiovascular Procedure Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      }
    }
  ]
}