{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204905",
      "product_res_number": "Z-0777-2024",
      "event_date_initiated": "2023-06-09",
      "event_date_posted": "2024-01-20",
      "recall_status": "Open, Classified",
      "res_event_number": "93580",
      "product_code": "MUI",
      "k_numbers": [
        "K130581"
      ],
      "product_description": "REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292",
      "code_info": "Lot Nos. SJ10091019 \tSJ22111019 \tSJ01041120 \tSJ25081020 \tSJ25061020 \tSJ20111020 \tSJ11021021 \tSJ24061021 \tSJ03061021 \tSJ14071021 \tSJ20091021 \tSJ09091021 \tSJ06022023 \tSJ10091019",
      "firm_fei_number": "3009482034",
      "recalling_firm": "Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.",
      "address_1": "no 45/5 akcaburgaz mahallesi muhsin yazicioglu caddesi",
      "city": "Esenyurt",
      "country": "Turkey",
      "additional_info_contact": "Secil Pala\n212-428 68 48",
      "reason_for_recall": "Sterility of Ultrasound gel can not be guaranteed.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On June 5, 2023, Turkuaz issued a \"Field Safety Notice to affected consignee(s). On December 13, 2023, an updated notification was provided to affected consignee(s) Turkuaz asked consignees to return the recalled items or destroy them. \n\nIf you have any questions, email the Quality Director at secil.pala@turkuazsaglik.com.tr .",
      "product_quantity": "4,923,471",
      "distribution_pattern": "US distribution to: Illinois and OUS (foreign) distribution to: Hong Kong",
      "openfda": {
        "k_number": [
          "K033178",
          "K020956",
          "K827296",
          "K112827",
          "K083358",
          "K242167",
          "K013212",
          "K151070",
          "K031222",
          "K131905",
          "K190591",
          "K021132",
          "K211691",
          "K130041",
          "K102683",
          "K163024",
          "K163023",
          "K031018",
          "K241789",
          "K181363",
          "K042619",
          "K232957",
          "K221999",
          "K163027",
          "K030889",
          "K130581",
          "K252337",
          "K253255",
          "K163026",
          "K031894",
          "K121311",
          "K163050",
          "K072515",
          "K102637"
        ],
        "registration_number": [
          "9710018",
          "3008502431",
          "3009482034",
          "2011171",
          "3031569584",
          "3008177921",
          "3013595964",
          "3014317667",
          "3006636956",
          "1417592",
          "1030451",
          "3007143236",
          "2435946",
          "1423537",
          "9710388",
          "3008751375",
          "1649518",
          "9616088",
          "9616874",
          "2950776",
          "3003623887",
          "3016447251",
          "2212018",
          "1061124",
          "1037885",
          "3012316249",
          "3011767724",
          "3009437400"
        ],
        "fei_number": [
          "3003445500",
          "3008502431",
          "3009482034",
          "2011171",
          "3002902735",
          "3031569584",
          "3008177921",
          "3001236277",
          "3013595964",
          "1000135740",
          "3014317667",
          "3001236905",
          "1000137528",
          "3006403682",
          "3006636956",
          "1417592",
          "1030451",
          "3007143236",
          "3008751375",
          "3003340745",
          "1000512168",
          "3003623887",
          "3016447251",
          "2212018",
          "1037885",
          "3012316249",
          "3011767724",
          "3009437400"
        ],
        "device_name": "Media, Coupling, Ultrasound",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1570",
        "device_class": "2"
      }
    }
  ]
}