{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "218402",
      "product_res_number": "Z-1461-2026",
      "event_date_initiated": "2026-01-14",
      "event_date_posted": "2026-02-24",
      "recall_status": "Open, Classified",
      "res_event_number": "98303",
      "product_code": "KPL",
      "product_description": "PIE Trolley System\nModel: 2005",
      "code_info": "All Lots",
      "firm_fei_number": "1000511598",
      "recalling_firm": "Edermy LLC",
      "address_1": "115 Enterprise Dr Ste A 115 Enterprise Dr",
      "address_2": "Ste A",
      "city": "Pendergrass",
      "state": "GA",
      "postal_code": "30567-4701",
      "reason_for_recall": "Lack of 510K clearance",
      "root_cause_description": "No Marketing Application",
      "action": "On January 14, 2026 PieMed issued a Urgent: Medical Device Recall Notification to affected consignees via mail. PieMed asked consignees to take the following actions: \n\n1. Discontinue use of the PIE 2005 Trolley System and PIE PAK Components.\n\n2. Secure and retain the PIE 2005 Trolley System and any unused PIE PAK kits in a controlled location to prevent further use.\n\n3. Consult with a healthcare provider regarding continuation of care and alternative treatment options, as appropriate.\n\n4. You may complete acknowledgement and receipt form in 2 weeks.\n\n5. Please ensure this notification is provided to all affected individuals. If the device has been transferred to a different location, please ensure they are provided with a copy of the communication.\n\n6. No further action should be taken with the affected device(s) unless directed by PIEMed.",
      "product_quantity": "27 units",
      "distribution_pattern": "US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.",
      "openfda": {
        "k_number": [
          "K000388",
          "K885092",
          "K800565",
          "K803105",
          "K770966",
          "K781923",
          "K902993",
          "K870127",
          "K201861",
          "K962259",
          "K002102",
          "K972455",
          "K873948",
          "K051344",
          "K003720",
          "K891585",
          "K033149",
          "K860943",
          "K150381",
          "K893531",
          "K980868",
          "K894209",
          "K050112",
          "K870376",
          "K941279",
          "K071057",
          "K973256",
          "K152834",
          "K970482",
          "K094022",
          "K881720",
          "K131852",
          "K942867",
          "K842083",
          "K000031",
          "K870534",
          "K050992",
          "K180800",
          "K840613",
          "K863539"
        ],
        "registration_number": [
          "1223925",
          "2433012",
          "1648139",
          "1062839",
          "3043011436",
          "2027347",
          "3042228064",
          "3005346382",
          "1320894",
          "3043012240",
          "3007305485",
          "9615415",
          "3043012074"
        ],
        "fei_number": [
          "1000305720",
          "2433012",
          "3001451571",
          "3043011436",
          "2027347",
          "3042228064",
          "3005346382",
          "3006329956",
          "3043012240",
          "3000718678",
          "3007305485",
          "1000516428",
          "3043012074"
        ],
        "device_name": "Colonic Irrigation System",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5220",
        "device_class": "2"
      }
    }
  ]
}