{
  "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": "2026-09-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tulsa",
      "state": "OK",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99515",
      "recalling_firm": "F & A Foundation",
      "address_1": "6303 E 102nd St",
      "address_2": "N/A",
      "postal_code": "74137-7041",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.",
      "recall_number": "Z-3211-2026",
      "product_description": "Reign Medical Clench Staple System (Compression), Description/REF:   9mm x 7mm/152-30907;   11mm x 10mm/152-31110;  15mm x 12mm/152-31512;  18mm x 18mm/152-31818;  20mm x 20mm/152-32020;  9mm x 7mm/152-40907;  11mm x 10mm/152-41110;  15mm x 12mm/152-41512;   18mm x 18mm/152-41818;  20mm x 20mm/152-42020",
      "product_quantity": "600",
      "reason_for_recall": "Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.",
      "recall_initiation_date": "20260715",
      "center_classification_date": "20260917",
      "report_date": "20260923",
      "code_info": "REF/UDI-DI/Lot/Expiration:  152-30907/00854325007011/24-0627/10/27/2029,  152-31110/00854325007028/24-0628/10/21/2029,  152-31512/00854325007042/24-0629/10/22/2029,  152-31818/00854325007073/24-0630/10/23/2029,  152-32020/00854325007189/24-0631/10/28/2029,  152-40907/00854325007010/24-0633/10/16/2029,  152-41110/00854325007127/24-0634/10/20/2029,  152-41512/00854325007141/24-0635/10/20/2029,  152-41818/00854325007172/24-0636/10/16/2029,  152-42020/00854325007189/24-0637/10/16/2029",
      "more_code_info": ""
    }
  ]
}