{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Denver",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99465",
      "recalling_firm": "Henry Schein Inc.",
      "address_1": "41 Weaver Rd",
      "address_2": "N/A",
      "postal_code": "17517-9308",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Barbados.",
      "recall_number": "Z-3016-2026",
      "product_description": "Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes:    1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145  2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065  3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099  4) 949-3597, Mfr Product Code 1843; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures.",
      "product_quantity": "853 units",
      "reason_for_recall": "Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.",
      "recall_initiation_date": "20260709",
      "center_classification_date": "20260825",
      "report_date": "20260902",
      "code_info": "Product Codes:   1) 949-3594, Mfr Product Code 1840, Lot Numbers:  2529604, 2538147, 2608145;  2) 949-3595, Mfr Product Code 1841, Lot Numbers:  2539075, 2539313, 2609789, 2539065;  3) 949-3596, Mfr Product Code 1842, Lot Numbers:  2536632, 2609174, 2610099;  4) 949-3597, Mfr Product Code 1843, Lot Numbers:  2535296, 2537418, 2607283."
    }
  ]
}