{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "167185",
      "product_res_number": "Z-0098-2019",
      "event_date_initiated": "2018-09-04",
      "event_date_created": "2018-10-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-27",
      "res_event_number": "80993",
      "product_code": "HEW",
      "k_numbers": [
        "K954311"
      ],
      "product_description": "Colpo-Pneumo Occluder, Part CPO-6",
      "code_info": "Lots 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 24 7609, 247610, & 248112",
      "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 seal of the sterile pouch may be compromised, thereby increasing the risk of infection.",
      "root_cause_description": "Other",
      "action": "Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers.  The letters instruct customers do the following:  \n\nPlease be advised that CooperSurgical has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches.  If any product from the 26 lots is in your possession and has a green label affixed to the outer display box as displayed below, it is not affected by this recall action.\n\nA product is acceptable for use if it is visually confirmed that the pouchs seal is intact. As indicated in the Directions for Use (DFU), each package should be handled with care and inspected for damage, including the seal area before use. Inspect the package contents and the sterile seal along the entire periphery of the package. Refer to the table below for examples of acceptable / not acceptable conditions.\n\nPlease discontinue use of the product with any packaging irregularities, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Once the form is completed and returned to CooperSurgical, a Customer Service Representative will contact you with a Return Merchandise Authorization (RMA) number and provide instructions for the return of product to CooperSurgical. If replacements are requested, a replacement order will be placed immediately. If you do not have affected stock, please complete and return the enclosed Acknowledgement and Receipt Form, in order for us to document receipt of this letter.",
      "product_quantity": "32538",
      "distribution_pattern": "The products were distributed to the following US states:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.\n\nThe products were distributed to the following foreign countries:  Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.",
      "openfda": {
        "k_number": [
          "K980972",
          "K993804",
          "K962881",
          "K110819",
          "K964276",
          "K243152",
          "K033728",
          "K051594",
          "K111014",
          "K201086",
          "K051160",
          "K161065",
          "K143650",
          "K191294",
          "K992655",
          "K180429",
          "K954311",
          "K143308"
        ],
        "registration_number": [
          "3007156625",
          "2032098",
          "1216677",
          "1519132",
          "1320468",
          "2528981",
          "3009763019",
          "1836161",
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          "3010202439",
          "2027111",
          "3008693678",
          "3009051888",
          "2020550",
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          "8030607",
          "1418479",
          "3011050570",
          "9611102",
          "2246552",
          "3012783431",
          "3003790304"
        ],
        "fei_number": [
          "3002750084",
          "3006509795",
          "3008133910",
          "1216677",
          "1519132",
          "3000206455",
          "2528981",
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          "3009051888",
          "3002808001",
          "2020550",
          "1627186",
          "1418479",
          "3011050570",
          "2246552",
          "3012783431",
          "3003058448",
          "3003790304"
        ],
        "device_name": "Culdoscope (And Accessories)",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.1640",
        "device_class": "2"
      }
    }
  ]
}