{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "73266",
      "product_res_number": "Z-0178-2009",
      "event_date_initiated": "2008-09-08",
      "event_date_posted": "2008-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-08-29",
      "res_event_number": "49406",
      "product_code": "LFK",
      "k_numbers": [
        "K955446"
      ],
      "product_description": "VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator, REF 60-6085-100.  Made in USA, CONMED CORPORATION, UTICA, NEW YORK USA 13502.  \nThe ConMed VCARE Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.",
      "code_info": "Lots 0710121x  through and including 0804111x [yymmddx  where x = shift code 1,2, or 3] . All lots of the recalled devices were manufactured between and including October 12, 2007 and April 11, 2008.",
      "firm_fei_number": "3001451571",
      "recalling_firm": "ConMed Corporation",
      "address_1": "525 French Road",
      "city": "Utica",
      "state": "NY",
      "postal_code": "13502",
      "additional_info_contact": "Ms. Patricia Cotter\n315-624-3533",
      "reason_for_recall": "The firm received several complaints sighting detachment of the balloon at the distal end of the shaft.  It was also noted that the incidence of the forward cup slipping off the shaft and being retained in the vaginal canal had increased.",
      "root_cause_description": "Process change control",
      "action": "The domestic recall notices were mailed on 9/08/08 by USP Priority Mail pouches. The international notices were sent via FedEx International Priority on 9/08/08.  The letter described the problem, the health risk and requested that customers inventory the product and return them back to the firm.  Customers are requested to fax the reply form to the firm.  Contact ConMed Corporation at 1-800-765-8375, ext 3237 for assistance.",
      "product_quantity": "32,453 (total devices)",
      "distribution_pattern": "Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland",
      "openfda": {
        "k_number": [
          "K820237",
          "K863218",
          "K915215",
          "K860810",
          "K914936",
          "K862771",
          "K891763",
          "K854612",
          "K831828",
          "K880775",
          "K971897",
          "K891764",
          "K890717",
          "K882466",
          "K830674",
          "K865096"
        ],
        "device_name": "Catheter, Femoral",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2",
        "registration_number": [
          "2030624",
          "2527072",
          "3003915875",
          "1722746",
          "2518902",
          "3005987240"
        ],
        "fei_number": [
          "2527072",
          "3003915875",
          "1000306216",
          "2518902",
          "3000206435",
          "3005987240"
        ]
      }
    }
  ]
}