{
  "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": "Ongoing",
      "city": "Bristol",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85034",
      "recalling_firm": "Gentell, Inc",
      "address_1": "2701 Bartram Rd",
      "address_2": "N/A",
      "postal_code": "19007-6810",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution \u0013 US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.",
      "recall_number": "Z-1624-2020",
      "product_description": "Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.",
      "product_quantity": "20,025",
      "reason_for_recall": "During an FDA audit, it was discovered that the product was not properly registered with FDA.",
      "recall_initiation_date": "20200227",
      "center_classification_date": "20200401",
      "report_date": "20200408",
      "code_info": "1134117  1101918  1107518  1114918  1121118  1127718  1131018  1133218  1135118  1105919  1118819  1121419  1124919"
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}