{
  "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": 16
    }
  },
  "results": [
    {
      "cfres_id": "220722",
      "product_res_number": "Z-2581-2026",
      "event_date_initiated": "2026-02-27",
      "event_date_posted": "2026-06-25",
      "recall_status": "Open, Classified",
      "res_event_number": "99062",
      "product_code": "OEQ",
      "product_description": "Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes.\n\nANGIOGRAM PACK-LF\t\t\n\tDYNJ21574J\t\n\nJUDKINS PACK\t\t\n\tDYNJ51126",
      "code_info": "DYNJ21574J\t\t\nUDI-DI\n\t10889942153497\t\nLots\n\t\t21ALA586\n\t\t21CLA398\n\t\t21ELA408\n\t\t21FLA144\n\t\t21FLA788\n\t\t21HLA420\n\t\t21ILA431\n\n\nDYNJ51126\t\t\nUDI-DI\n\t10889942122820\t\nLots\n\t\t21ADA917",
      "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": "Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA.\nProducts not initially reported in RES 98601.",
      "root_cause_description": "No Marketing Application",
      "action": "This entry catalogues SKUs communicated through the same letter documented in RES 98601 which were inadvertently missed in the initial report to the FDA.\n\nFirm began notifying customers on February 27, 2026 via letters titled \"URGENT MEDICAL DEVICE RECALL\". \n\nCustomers were instructed to immediately check stock for affected product and quarantine any affected units. Upon receipt of the customers' response form reporting the quantity of affected product on hand, the firm will provide over-labels to place on affected inventory. Labels contain instructions for staff to remove and discard the affected component prior to using the kit.",
      "product_quantity": "113,843 kits",
      "distribution_pattern": "US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, \nKY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, \nWY and the country of Barbados.",
      "openfda": {
        "registration_number": [
          "3015225571",
          "3014925393",
          "2030624",
          "3007329020",
          "1054241",
          "3008513424",
          "1643817",
          "3009605245",
          "3045816907",
          "1043214",
          "1423537",
          "1061124",
          "3006950086",
          "3009888344",
          "3004605321",
          "3012536737",
          "3004122598",
          "3011642792",
          "3005012805",
          "3033589330",
          "3007289408",
          "1319639",
          "2320762",
          "3004111573",
          "1055236",
          "3002807314",
          "3004519921",
          "1030451",
          "3035642068",
          "1018470",
          "3012964172",
          "1625425",
          "1422634",
          "1721676",
          "9616088",
          "3015173212",
          "1125782",
          "3007138831",
          "3015309643",
          "2029015",
          "3004911384",
          "3015910259",
          "1928237",
          "3005595283",
          "3045816902",
          "1047429",
          "3002834291",
          "1423395",
          "1123137",
          "1724474",
          "9616662",
          "1721504"
        ],
        "fei_number": [
          "3015225571",
          "3014925393",
          "3000206435",
          "3007329020",
          "3008513424",
          "3003040625",
          "1643817",
          "3009605245",
          "3045816907",
          "1043214",
          "1000112968",
          "3006950086",
          "3009888344",
          "3004605321",
          "3012536737",
          "3004122598",
          "3011642792",
          "3005012805",
          "1000112877",
          "3002975287",
          "3033589330",
          "3007289408",
          "3000717925",
          "1000514656",
          "3004111573",
          "3000335778",
          "1000123180",
          "3002807314",
          "3035642068",
          "1018470",
          "1000138054",
          "3012964172",
          "1625425",
          "3003094851",
          "1000160458",
          "1721676",
          "3005846326",
          "3015173212",
          "3007138831",
          "3015309643",
          "3004911384",
          "3015910259",
          "3001236905",
          "1928237",
          "3005595283",
          "3045816902",
          "1047429",
          "3002834291",
          "1000512168",
          "1030451",
          "1721504",
          "3002902735"
        ],
        "device_name": "Angiography/Angioplasty Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1650",
        "device_class": "2"
      }
    }
  ]
}