{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Fidenza",
      "state": "N/A",
      "country": "Italy",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87680",
      "recalling_firm": "Omnia SRL",
      "address_1": "Via Fratelli Cairoli 5",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic: AK, IL, PA, OK, TX, UT, NY, CA. Foreign: Australia, Austria, Belgium, Bulgaria, Denmark, Dominican Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Lebanon, Netherlands, New Zealand, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, Uzbekistan, Canada, Malta,",
      "recall_number": "Z-1518-2021",
      "product_description": "Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel.   Model: 32.Z2000.00, 32.Z2002.00, 32.Z2004.00, 32.Z2006.00, 32.Z2007.00,  32.Z2008.00, 32.Z2009.00, 32.Z2020.00, 32.Z2022.00, 32.Z2024.00,  32.Z2026.00, 32.Z2027.00, 32.Z2028.00, 32.Z2030.00, 32.Z2032.00,  32.Z2034.00, 32.Z2036.00, 32.Z2038.00, 32.Z2040.00, 72.T1950.00,  72.T1951.00, 72.T1952.00, 72.T1953.00",
      "product_quantity": "276,901 units",
      "reason_for_recall": "Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.",
      "recall_initiation_date": "20210330",
      "center_classification_date": "20210429",
      "termination_date": "20231108",
      "report_date": "20210505",
      "code_info": "Lot:118, 317, 319, 516, 616, 617, 618, 620, 716, 719, 720, 817, 818, 916, 920, 1016, 1018, 1216, 1217, 1316, 1317, 1318, 1319, 1418, 1516, 1618, 1718, 1720, 1816, 1817, 1918, 1919, 2018, 2117, 2118, 2119, 2216, 2316, 2319, 2416, 2417, 2619, 2713, 2717, 2718, 2719, 2816,2818, 2819, 2916, 3218, 3219, 3416, 3517,3716, 3719, 3816, 3818, 3916, 3917, 3918, 3919, 4118, 4217, 4220, 4318, 4320, 4416, 4417, 4419, 4617, 4715, 4716, 4816, 4819, 4820, 4915, 4920, 5118, 5319, 0317, 190B, 1920A, 1920B, 2518A, 2518B, 4820A",
      "more_code_info": ""
    }
  ]
}