{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "186327",
      "product_res_number": "Z-1519-2021",
      "event_date_initiated": "2020-12-07",
      "event_date_created": "2021-04-30",
      "recall_status": "Open, Classified",
      "res_event_number": "87577",
      "product_code": "MXP",
      "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.",
      "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",
      "firm_fei_number": "2021687",
      "recalling_firm": "Oto Med Inc",
      "address_1": "1090 Empire Dr",
      "city": "Lake Havasu City",
      "state": "AZ",
      "postal_code": "86404-2429",
      "additional_info_contact": "Dorothy Gammage\n866-472-2363",
      "reason_for_recall": "During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.",
      "root_cause_description": "Package design/selection",
      "action": "On 12/07/2020, the firm sent an \"URGENT: PRODUCT RECALL NOTICE\" Letter via FedEx Overnight (U.S.) and email (O.U.S.) to customer informing them that there is a potential for a hole to develop in the packaging during handling/shipment.\n\nCustomers are instructed to:\n1) Check their inventory for any holes or damage to the pouches, and disposition as specified below:\n-My inventory has been checked and included none of the affected products.\n-My inventory has been checked and has no damaged pouches; The product is not being returned.\n-My inventory has been checked and the product listed is being returned.\n\nIf returning products, please obtain a Returned Authorization (RA) number.  The RA number may be obtained from Customer Service (866-472-2363).  In addition, the Response Form must be completed and returned to Grace Medical Group at RECALL COORDINATOR, OTO-MED, INC. c/o GRACE MEDICAL GROUP, INC.,  8500 Wolf Lake Drive, Suite 110, Memphis, TN 38133, or by fax to 901-386-0950 or email at info@gracemedical.com.",
      "product_quantity": "13,335 devices",
      "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.",
      "openfda": {
        "registration_number": [
          "3003418325",
          "2085199",
          "3002808270",
          "3011554142",
          "3016965929",
          "3015136927",
          "1421873",
          "3003963832",
          "8040278",
          "1422507",
          "3006017180",
          "2029275",
          "3002987066",
          "2183650",
          "1057421",
          "9616119",
          "3042244310",
          "9680837"
        ],
        "fei_number": [
          "3003418325",
          "3002808270",
          "1000306431",
          "3011554142",
          "3015136927",
          "3016965929",
          "3001032747",
          "3003963832",
          "3004216008",
          "3001237209",
          "1000022662",
          "3006017180",
          "3003249645",
          "1000160732",
          "2183650",
          "1000159990",
          "3042244310",
          "3002987066"
        ],
        "device_name": "Bone Particle Collector",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.4800",
        "device_class": "1"
      }
    }
  ]
}