{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 6
    }
  },
  "results": [
    {
      "cfres_id": "222821",
      "product_res_number": "Z-0180-2027",
      "event_date_initiated": "2026-08-31",
      "event_date_posted": "2026-10-15",
      "recall_status": "Open, Classified",
      "res_event_number": "99888",
      "product_code": "FDE",
      "product_description": "Convenience Kits containing CONMED AirSeal Access Ports\n\nADVANCE LAPAROSCOPIC\t\n\tDYNJ911135\n\t\nLAP CHOLE\t\n\tDYNJ911660\n\t\nLAP NISSEN\t\n\tDYNJ911560\n\nUROLOGY LAPAROSCOPIC - 51638\t\n\tDYNJ908720A",
      "code_info": "DYNJ911135\t\t\n\tUDI-DI 10198459264382\t\n\t\tLots 25EDA279\n\t\t25FDB612\n\t\t25LDB658\n\t\t\nDYNJ911660\t\t\n\tUDI-DI 10198459487071\t\n\t\tLots 25IMF444\n\t\t25JMA458\n\t\t26BMG519\n\t\t26DMA914\n\t\t26EMA779\n\t\t26FME775\n\t\t26GMA849\n\t\t26GMF826\n\t\t26GMM101\n\t\t26GMM127\n\t\t\nDYNJ911560\t\t\n\tUDI-DI 10198459400261\t\n\t\tLots 25HMG749\n\t\t25JMC886\n\t\t25KMA383\n\t\t25KMA392\n\t\t\nDYNJ908720A\t\t\n\tUDI-DI 10195327423155\t\n\t\tLots 24DBN292\n\t\t24GBJ114\n\t\t24IBK504\n\t\t24JBC471\n\t\t25KBP733\n\t\t26ABG732",
      "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\n800-633-5463",
      "reason_for_recall": "Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.",
      "root_cause_description": "Process change control",
      "action": "The firm began notifying customers on August 31, 2026. \n\nCustomers were provided with CONMED's original recall notification, which instructs users to have a replacement AirSeal disposable be available prior to the procedure in order to minimize potential delays. \n\nUsers should ensure tubing is properly connected between the tube set and access ports prior to initiating insufflation. If the connection cannot be securely tightened and the \"overpressure\" alert cannot be resolved, users should replace the affected device.\n\nUsers were also provided with instructions on how to connect the AirSeal tubeset and access ports, which include new figures as an update to the prior Instructions for Use.\n\nThe corrected Instructions for Use are available electronically at eifu.conmed.com/eifu.",
      "product_quantity": "3,551 kits",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.",
      "openfda": {
        "device_name": "Laparoscopy Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "k_number": [
          "K955717",
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