{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "187244",
      "product_res_number": "Z-1686-2021",
      "event_date_initiated": "2021-04-23",
      "event_date_created": "2021-05-26",
      "recall_status": "Open, Classified",
      "res_event_number": "87849",
      "product_code": "HEW",
      "k_numbers": [
        "K954311"
      ],
      "product_description": "The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex.\n\nModel Number(s):\tKCP-30-2",
      "code_info": "Lot 280819",
      "firm_fei_number": "1216677",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "95 Corporate Dr",
      "city": "Trumbull",
      "state": "CT",
      "postal_code": "06611-1350",
      "additional_info_contact": "Customer Service\n203-601-9818",
      "reason_for_recall": "The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.",
      "root_cause_description": "Labeling design",
      "action": "On 04/30/2021, Cooper Surgical issued an Urgent Medical Device Removal notice to customers via letter notifying them Cooper Surgical is issuing this recall due to a labeling discrepancy with respect to the cup size, where a 3.5cm Ultem Cup was placed in the Product rather than a 3.0cm Ultem Cup as indicated by the Part Number on the packaging label.",
      "product_quantity": "6 boxes or 12 units",
      "distribution_pattern": "Domestic: UT, OH, DE",
      "openfda": {
        "k_number": [
          "K051594",
          "K962881",
          "K033728",
          "K110819",
          "K201086",
          "K143308",
          "K993804",
          "K191294",
          "K180429",
          "K161065",
          "K954311",
          "K143650",
          "K980972",
          "K111014",
          "K051160",
          "K243152",
          "K992655",
          "K964276"
        ],
        "registration_number": [
          "8030607",
          "3008254127",
          "1216677",
          "3011050570",
          "3012783431",
          "3010202439",
          "3007156625",
          "1320468",
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          "3009051888",
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          "3003790304",
          "3009763019",
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        ],
        "fei_number": [
          "1216677",
          "3008254127",
          "3011050570",
          "3012783431",
          "3002808001",
          "3007475226",
          "3003058448",
          "2027111",
          "3008133910",
          "3009051888",
          "2020550",
          "3006509795",
          "2528981",
          "2246552",
          "3002750084",
          "3000206455",
          "3003790304",
          "3009763019",
          "1627186",
          "1418479",
          "1519132",
          "3008693678"
        ],
        "device_name": "Culdoscope (And Accessories)",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.1640",
        "device_class": "2"
      }
    }
  ]
}