{
  "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": 10
    }
  },
  "results": [
    {
      "cfres_id": "186342",
      "product_res_number": "Z-1355-2021",
      "event_date_initiated": "2020-12-23",
      "event_date_created": "2021-04-06",
      "recall_status": "Open, Classified",
      "res_event_number": "87581",
      "product_code": "MQF",
      "product_description": "At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)",
      "code_info": "All lots",
      "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.",
      "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.",
      "product_quantity": "Unknown",
      "distribution_pattern": "World-wide distribution.",
      "openfda": {
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        ],
        "device_name": "Catheter, Assisted Reproduction",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.6110",
        "device_class": "2"
      }
    }
  ]
}