{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Arden",
      "address_1": "25 Heywood Rd",
      "reason_for_recall": "Potential compromise of product sterility due to breach of sterile barrier.",
      "address_2": "",
      "product_quantity": "13 cases (2,600 sponges)",
      "code_info": "Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111",
      "center_classification_date": "20181222",
      "distribution_pattern": "Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI.  No product was distributed outside of the US.",
      "state": "NC",
      "product_description": "Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap.    intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.",
      "report_date": "20190102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medical Action Industries Inc",
      "recall_number": "Z-0681-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81640",
      "termination_date": "20190208",
      "more_code_info": "",
      "recall_initiation_date": "20181127",
      "postal_code": "28704-9302",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}