{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "130767",
      "product_res_number": "Z-0208-2015",
      "event_date_initiated": "2014-09-30",
      "event_date_posted": "2014-11-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-05-28",
      "res_event_number": "69500",
      "product_code": "HHW",
      "k_numbers": [
        "K904026",
        "K904774"
      ],
      "product_description": "CooperSurgical MILEX PESSARY KITS-\r\nHodge w/Support Folding Pessary- #1\r\nModel: MXKPHS01\r\n\r\n \r\nProduct Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues",
      "code_info": "Lot Number: 142921",
      "firm_fei_number": "1216677",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "75 Vista Pl",
      "city": "Trumbull",
      "state": "CT",
      "postal_code": "06611-3934",
      "additional_info_contact": "203-601-5200",
      "reason_for_recall": "Incorrect expiration date printed on the MILEX PESSARY KIT packaging",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "CooperSurgical notified customers a Recall Notification dated September 29, 2014, via UPS . The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical's will replace any of the affected and provided further instruction on the disposition of the product at the time of replacement. \r\n\r\nIf you have any further questions, contact 203.601.5200.\r\n.",
      "product_quantity": "6 units",
      "distribution_pattern": "US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL",
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        "device_name": "Pessary, Vaginal",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.3575",
        "device_class": "2"
      }
    }
  ]
}