{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Modi'in",
      "state": "N/A",
      "country": "Israel",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89309",
      "recalling_firm": "FEMSelect Ltd",
      "address_1": "HaMa'ayan 2",
      "address_2": "First Floor",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide distribution in the state of Georgia.",
      "recall_number": "Z-0556-2022",
      "product_description": "The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity.   The anchors are pre-loaded inside the device shaft and are ready for use.   A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace.   Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.",
      "product_quantity": "141 units",
      "reason_for_recall": "Certain lots may not have been packaged wth the Channel Tube Limiter.",
      "recall_initiation_date": "20211213",
      "center_classification_date": "20220202",
      "report_date": "20220209",
      "code_info": "UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers:  21072510 and 21072512."
    }
  ]
}