{
  "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": 9
    }
  },
  "results": [
    {
      "cfres_id": "188161",
      "product_res_number": "Z-2175-2021",
      "event_date_initiated": "2020-12-23",
      "event_date_created": "2021-08-02",
      "recall_status": "Open, Classified",
      "res_event_number": "88225",
      "product_code": "MQF",
      "product_description": "Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001",
      "code_info": "All lots sold prior to December 9, 2019.",
      "firm_fei_number": "3012228225",
      "recalling_firm": "Tenderneeds Fertility LLC",
      "address_1": "10162 Bradford Rd",
      "city": "Greenville",
      "state": "IN",
      "postal_code": "47124-9227",
      "additional_info_contact": "260-337-8453",
      "reason_for_recall": "Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.",
      "root_cause_description": "No Marketing Application",
      "action": "On December 23, 2020, the firm published a recall notification on its website at the following URL: https://tenderneedsfertility.com/recalls. \n\nThe notification notified customers that all IUI and ICI kits sold for human use were being recalled. Customers were instructed to destroy these products, including leftover portions, immediately. The firm did not ask customers to return the product.\n\nThis event was previously recorded under RES 87851.\n\nOn June 9, 2021, firm updated recall communication on website to include more information about the recall. All IUI and ICI kits sold for human use by the firm prior to December 9, 2019 are subject to the recall. Some of the products listed in the notice were not previously captured by FDA's summary. This event (RES 88225) was created to document these additional products.",
      "product_quantity": "Unknown",
      "distribution_pattern": "Worldwide distribution.",
      "openfda": {
        "k_number": [
          "K162064",
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          "K120154",
          "K173686",
          "K163318",
          "K172321",
          "K000656",
          "K162878"
        ],
        "registration_number": [
          "3005987240",
          "9617744",
          "9612445",
          "3003995932",
          "1047843",
          "1450662",
          "1820334",
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          "3005580113",
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          "3008876063",
          "3017247483",
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        ],
        "fei_number": [
          "3005987240",
          "3003995932",
          "1047843",
          "1450662",
          "3002807433",
          "1820334",
          "2246552",
          "3010155661",
          "3006279007",
          "3009337401",
          "3017896194",
          "3003015552",
          "3014295858",
          "3015136743",
          "1000514656",
          "3002807969",
          "3043639843",
          "3003474731",
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          "3002808026",
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          "3002807111",
          "3007800906",
          "3005580113",
          "3014755376",
          "3015453963",
          "3008876063",
          "3017247483"
        ],
        "device_name": "Catheter, Assisted Reproduction",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.6110",
        "device_class": "2"
      }
    }
  ]
}