{
  "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": "140171",
      "product_res_number": "Z-0253-2016",
      "event_date_initiated": "2015-09-14",
      "event_date_posted": "2015-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-01-08",
      "res_event_number": "72204",
      "product_code": "HHW",
      "k_numbers": [
        "K904774"
      ],
      "product_description": "MILEX PESSARY KIT; Model Numbers: MXPES00; MXKPES00; MXKPREG03; MXKPGSK07\n\nProduct Usage:\nThe Coopersurgical MILEX SILICONE PESSARY is used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence.",
      "code_info": "MXPES00: Lot139411; 157299; 180533 MXKPES00: Lot 125143; 142853 MXKPREG03: Lot 153096 MXKPGSK07: Lot 157364; 160432",
      "firm_fei_number": "1216677",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "75 Corporate Dr",
      "city": "Trumbull",
      "state": "CT",
      "postal_code": "06611-1350",
      "additional_info_contact": "Customer Service\n203-601-9818",
      "reason_for_recall": "The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on\nthe packaging does not meet the required release specification.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Cooper Surgical sent an Urgent Medical Device Recall letter dated September 14, 2015 via FedEx with confirmed delivery receipt.  The letter identified the affected product, problem and actions to be taken.  Customers were asked to  discontinue use of the affected products and complete the Acknowledgement and Receipt form for a free replacement.  For questions contact Product Surveillance at 203.601.5200 ext. 3300.",
      "product_quantity": "144 units",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AR, CA, CO, GA, IL, KY, LA, MA, MD, MI, MT, NC, NY, OH, OK, PA, RI, SD, VA, WA, WI,WV and in the countries of FRANCE and VIETNAM.",
      "openfda": {
        "k_number": [
          "K933654",
          "K781863",
          "K240798",
          "K092981",
          "K153422",
          "K250438",
          "K965040",
          "K974117",
          "K990593",
          "K012277",
          "K974116",
          "K904026",
          "K231786",
          "K190277",
          "K974115",
          "K930618",
          "K173351",
          "K232525",
          "K771548",
          "K890565",
          "K131198",
          "K253698",
          "K920187",
          "K920747",
          "K002329",
          "K083769",
          "K013289",
          "K031463",
          "K132313",
          "K020512",
          "K233548",
          "K032644",
          "K060526",
          "K993308",
          "K132670",
          "K883721",
          "K081385",
          "K904774",
          "K232677",
          "K151413",
          "K183468"
        ],
        "registration_number": [
          "1123010",
          "3029906631",
          "3016608162",
          "3024374351",
          "3014755376",
          "3036802560",
          "3003418325",
          "2084346",
          "1216677",
          "3000143502",
          "3007289408",
          "3031738269",
          "3021815",
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          "9710006",
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          "3013557562",
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          "3003701733",
          "3011109575",
          "2951215",
          "3007421149",
          "1450908",
          "3019039128",
          "3007137643",
          "3024860690",
          "8040510",
          "3005674485",
          "3010131137"
        ],
        "fei_number": [
          "3029906631",
          "3016608162",
          "3024374351",
          "3014755376",
          "3036802560",
          "1000124817",
          "3003418325",
          "1216677",
          "3000143502",
          "3007289408",
          "3031738269",
          "1000221492",
          "3021815",
          "3014295858",
          "3025325116",
          "3009513193",
          "3015417614",
          "1000312280",
          "3020160672",
          "3003968049",
          "3001319476",
          "2025182",
          "3031788248",
          "2523865",
          "3011529681",
          "2511556",
          "3002680121",
          "3015895045",
          "3013557562",
          "3003701733",
          "3011109575",
          "1000244733",
          "1000123297",
          "3007421149",
          "1450908",
          "3019039128",
          "3007137643",
          "3024860690",
          "3005674485",
          "3010131137"
        ],
        "device_name": "Pessary, Vaginal",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.3575",
        "device_class": "2"
      }
    }
  ]
}