{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lake Havasu City",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87577",
      "recalling_firm": "Oto Med Inc",
      "address_1": "1090 Empire Dr",
      "address_2": "N/A",
      "postal_code": "86404-2429",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in the states of MN, IL, PA, WI, GA, SD, FL, AR, MA, AZ, TX, MO, NC, CA, UT, DE, OR, IN, CO, AL, OH, NY, WA, DC, TN, NH, VT, VA, SC, MI, WI, MS, IA, NJ, MD, KS, CT, LA, ME, KY, HI, TN, RI, NV, ID and the countries of Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, India.",
      "recall_number": "Z-1519-2021",
      "product_description": "Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage:  intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.",
      "product_quantity": "13,335 devices",
      "reason_for_recall": "During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.",
      "recall_initiation_date": "20201207",
      "center_classification_date": "20210430",
      "report_date": "20210512",
      "code_info": "UDI Code:  00850000126046  Lot Numbers:  019120G(2)  029119G(2)  039118G(2)  049119G(2)  0712119G(2)  0812118G(2)  0912118G(2)  1012119G(2)  1212118G(2)  200401"
    }
  ]
}