{
  "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": "167064",
      "product_res_number": "Z-0091-2019",
      "event_date_initiated": "2018-08-06",
      "event_date_created": "2018-10-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-11-12",
      "res_event_number": "80939",
      "product_code": "MOL",
      "k_numbers": [
        "K072169"
      ],
      "product_description": "Polyisoprene condomns\n\nProduct Usage:\nThe Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).",
      "code_info": "Lot Number - 1000490884",
      "firm_fei_number": "3011015568",
      "recalling_firm": "Reckitt Benckiser LLC",
      "address_1": "399 Interpace Pkwy",
      "city": "Parsippany",
      "state": "NJ",
      "postal_code": "07054-1133",
      "additional_info_contact": "Lynn Kenney\n973-404-2494",
      "reason_for_recall": "Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On August 6,. 2018, Reckitt Benckiser issued Urgent Medical Device Recall notices to customers.  Customers were advised to take the following action:\n\nWholesale Customers:\n1. Examine inventory and quarantine affected product\n2. Contact customers and notify them of the recall and provide them with the recall instructions (copy of the letter).\n3. Customers are encouraged to contact Stericycle Expert Solutions at 877-448-5308 for assistance if additional return labels are required or help with coordination of pickup and removal of product from your facility.",
      "product_quantity": "34 cartons/12 condoms each (408 condoms total)",
      "distribution_pattern": "US in the states of NY",
      "openfda": {
        "k_number": [
          "K160399",
          "K962816",
          "K942697",
          "K240896",
          "K072169",
          "K182438",
          "K974121",
          "K252158",
          "K241617",
          "K971590",
          "K231908",
          "K171172",
          "K070800",
          "K001974",
          "K100767",
          "K171639",
          "K203541",
          "K243967",
          "K922688",
          "K955672",
          "K050828",
          "K240379",
          "K232470"
        ],
        "registration_number": [
          "3013770781",
          "9680135",
          "3003592318",
          "2531449",
          "3006122980",
          "9613932",
          "2280705",
          "3007829481",
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          "1122329",
          "1000136042",
          "2086832",
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          "3003896222",
          "3011015568"
        ],
        "fei_number": [
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          "3003592318",
          "3006122980",
          "3002921123",
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          "3010687142",
          "3007829481",
          "1000535235",
          "2938651",
          "3003071219",
          "3003491851",
          "1000136042",
          "3001687671",
          "3002808272",
          "3003979157",
          "1222115",
          "1122329",
          "3011015568"
        ],
        "device_name": "Condom, Synthetic",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.5300",
        "device_class": "2"
      }
    }
  ]
}