{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "25148",
      "product_res_number": "Z-0402-03",
      "event_date_initiated": "2002-11-25",
      "event_date_posted": "2002-12-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-10-15",
      "res_event_number": "25095",
      "product_code": "LTZ",
      "k_numbers": [
        "K000408",
        "K971132",
        "K981621"
      ],
      "product_description": "LifeStyles Assorted Colors Condoms with Spermicide",
      "code_info": "ANSELL HEALTHCARE INC.\t \t\t LOT NUMBER\tPRODUCT CODE\tDESCRIPTION  0912C01622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0912C01522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0912C01422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0912C01322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0912C01222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0912C01122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0911C00322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0911C00222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0911C00122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C02222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C02122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C02022\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C01922\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C01822\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C01722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C01622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C01522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0910C01422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0909C02722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0909C02522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0909C00722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0909C00622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0909C00522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0909C00422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0909C00322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0909C00222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04822\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C04022\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03922\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03822\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C03022\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C02922\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C02822\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C02722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C02622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C02522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C02422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C02322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0908C02222\t6000\tLS ASST CLRS W/SPL STPS 1000''S  0001990122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0001990222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0001990322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0001990422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0001990822\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0001990922\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0001991622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0001991922\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0001992122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0002990422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0002990522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990822\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0004990922\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990822\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005990922\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0005991022\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0006991222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0007991022\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0007991122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0007991222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0007991322\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0007991422\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0007991522\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0007991622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0007991722\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0008990622\t6003\tLS ASST COLORS W/SPL FP 3''S 0008990922\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0008991022\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0008991122\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0008991222\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0008992022\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0009991322\t6003\tLS ASST COLORS W/SPL FP 3''S 0009992122\t6003\tLS ASST COLORS W/SPL FP 3''S 0009992222\t6003\tLS ASST COLORS W/SPL FP 3''S 0106992622\t6000\tLS ASST CLRS W/SPL STPS 1000''S 0106992722\t6000\tLS ASST CLRS W/SPL STPS 1000''S",
      "firm_fei_number": "1019632",
      "recalling_firm": "Ansell Healthcare Inc",
      "address_1": "1500 Industrial Road",
      "city": "Dothan",
      "state": "AL",
      "postal_code": "36303",
      "additional_info_contact": "Phil Corke\n732-345-5400",
      "reason_for_recall": "The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards",
      "root_cause_description": "Other",
      "action": "Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.",
      "product_quantity": "approximately 40 million condoms",
      "distribution_pattern": "Nationwide and Europe",
      "openfda": {
        "k_number": [
          "K970791",
          "K992438",
          "K974324",
          "K033163",
          "K012969",
          "K972429",
          "K963322",
          "K952415",
          "K904273",
          "K003375",
          "K972836",
          "K974326",
          "K981955",
          "K953813",
          "K972430",
          "K981621",
          "K990669",
          "K001978",
          "K931220",
          "K010178",
          "K001377",
          "K991047"
        ],
        "device_name": "Condom With Nonoxynol-9",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.5310",
        "device_class": "2",
        "registration_number": [
          "3013770781",
          "3003592318",
          "2280705",
          "9613932",
          "3008808138",
          "3003759643",
          "3021234378",
          "3003491851",
          "9613994",
          "1000136042",
          "8040641",
          "1122329"
        ],
        "fei_number": [
          "3013770781",
          "3003592318",
          "2280705",
          "3003759643",
          "3009084570",
          "3021234378",
          "3003491851",
          "1000136042",
          "3001687671",
          "3002808272",
          "3008808138",
          "1122329"
        ]
      }
    }
  ]
}