{
  "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": 30
    }
  },
  "results": [
    {
      "cfres_id": "220382",
      "product_res_number": "Z-2479-2026",
      "event_date_initiated": "2026-05-04",
      "event_date_posted": "2026-06-17",
      "recall_status": "Open, Classified",
      "res_event_number": "98994",
      "product_code": "EYB",
      "k_numbers": [
        "K092250"
      ],
      "product_description": "MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes:  \n1.\tDYND13508 - 08 Fr;\n2.\tDYND13510 - 10 Fr;\n3.\tDYND13512 - 12 Fr;\n4.\tDYND13514 - 14 Fr;\n5.\tDYND13515 - 15 Fr;\n6.\tDYND13516 - 16 Fr;\n7.\tDYND13518 - 18 Fr;\n8.\tDYND13520 - 20 Fr;\n9.\tDYND13522 - 22 Fr;\n10.\tDYND13614 - 14 Fr;\n11.\tDYND13616 - 16 Fr.",
      "code_info": "1. DYND13508, UDI/DI 10080196031139 (each), 20080196031136 (case); \n2. DYND13510, UDI/DI 10080196726462 (each), 40080196726463 (case); \n3. DYND13512, UDI/DI 10080196031177 (each), 40080196031178 (case); \n4. DYND13514, UDI/DI 10080196726219 (each), 40080196726210 (case); \n5. DYND13515, UDI/DI 10080196031214 (each), 40080196031215 (case); \n6. DYND13516, UDI/DI 10080196031221 (each), 40080196031222 (case); \n7. DYND13518, UDI/DI 10080196031245 (each), 40080196031246 (case); \n8. DYND13520, UDI/DI 10080196031252 (each), 40080196031253 (case); \n9. DYND13522, UDI/DI 10080196061259 (each), 40080196061250 (case); \n10. DYND13614, UDI/DI 10080196031276 (each), 30080196031270 (case); \n11. DYND13616, UDI/DI 10888277720879 (each), 20888277720876 (case); \nALL LOTS",
      "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": "During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Medline Industries issued two URGENT MEDICAL DEVICE RECALL notice on 5/4/2026 to its consignees, one to its catheter and catheter tray consignees, and the other to the kit consignees via USPS and email.  Both notices explained the issue and potential risk.  The catheter and catheter tray consignees were directed to respond to the notice and destroy the affected products.  The kit consignees were directed to respond to the notice and apply additional labeling (over-labels) to affix to the kits which instruct the user to remove and destroy the affected component.  Both notices direct distributors or those who further distributing the products to notify their customers.  \nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.",
      "product_quantity": "2237471 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.",
      "openfda": {
        "k_number": [
          "K030293",
          "K133750",
          "K192183",
          "K032521",
          "K964899",
          "K941011",
          "K182695",
          "K182122",
          "K191187",
          "K941012",
          "K933020",
          "K033368",
          "K921838",
          "K962004",
          "K941010",
          "K043581",
          "K092250",
          "K930483",
          "K950300",
          "K083788",
          "K171043",
          "K914358",
          "K923729",
          "K180182",
          "K882130",
          "K021856",
          "K183323",
          "K020577"
        ],
        "registration_number": [
          "9681477",
          "3005515211",
          "1037955",
          "3016096097",
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          "3005941719",
          "9617592",
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          "2027111",
          "3009763019",
          "3000268902"
        ],
        "fei_number": [
          "3008133910",
          "3005515211",
          "1037955",
          "3016096097",
          "3002468371",
          "3003790304",
          "3005669815",
          "1820334",
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          "3012445205",
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          "3012050423",
          "3002807439",
          "3003915875",
          "1220477",
          "1313046",
          "3005099803",
          "3008502431",
          "3001124136",
          "3014579161",
          "3006082230",
          "3012649202",
          "3003814961",
          "1018233",
          "3002807111",
          "3011050570",
          "2027111",
          "3009763019",
          "3000268902",
          "3002913962",
          "1000306139"
        ],
        "device_name": "Catheter, Ureteral, Gastro-Urology",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5130",
        "device_class": "2"
      }
    }
  ]
}