{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "185082",
      "product_res_number": "Z-0874-2021",
      "event_date_initiated": "2020-12-21",
      "event_date_created": "2021-01-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-07-11",
      "res_event_number": "87034",
      "product_code": "BWF",
      "k_numbers": [
        "K002768"
      ],
      "product_description": "Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.",
      "code_info": "Model Number 21-1530, Lot Number 3988435, UDI 50788942215304",
      "firm_fei_number": "3012307300",
      "recalling_firm": "Smiths Medical ASD Inc.",
      "address_1": "6000 Nathan Ln N",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55442-1690",
      "additional_info_contact": "David Halverson\n763-383-3072",
      "reason_for_recall": "Shipping box may contain wrong model.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Urgent Medical Device Recall Notice (Ref # 3012307300-12/18/2020-014-R) will be sent to customers via tracked email during the week of December 21, 2020. Customers are instructed to send affected product to Smiths Medical.",
      "product_quantity": "4440",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, MD, ME, MI, MO, MS, NC, NE, NJ, OH, OR, PA, SC, TN, TX, UT, VA, WV and the countries of Austria, Canada, Chile, Czech Republic, France, Germany, Italy, Thailand.",
      "openfda": {
        "k_number": [
          "K810641",
          "K791842",
          "K140772",
          "K821492",
          "K983308",
          "K182847",
          "K160837",
          "K822359",
          "K022906",
          "K160636",
          "K760762",
          "K942919",
          "K192000",
          "K133873",
          "K984468",
          "K832878",
          "K781833",
          "K770619",
          "K771532",
          "K781831",
          "K233855",
          "K070490",
          "K241152",
          "K222018",
          "K972042",
          "K962749",
          "K983467",
          "K791819",
          "K861564",
          "K033401",
          "K792214",
          "K944412",
          "K991300",
          "K871742",
          "K221058",
          "K781838",
          "K893665",
          "K820528",
          "K800546",
          "K012368",
          "K173918",
          "K800386",
          "K994074",
          "K770141",
          "K954492",
          "K782016",
          "K091557",
          "K833337",
          "K781245",
          "K183108",
          "K842369",
          "K840418",
          "K873579",
          "K123400",
          "K870514",
          "K053149",
          "K792598",
          "K791015",
          "K864719",
          "K944344",
          "K141355",
          "K163091",
          "K912943",
          "K840239",
          "K945118",
          "K831142",
          "K972824",
          "K961077",
          "K871904",
          "K821998",
          "K780037",
          "K900754",
          "K970596",
          "K040084",
          "K801199",
          "K780265",
          "K150173",
          "K790744",
          "K172388",
          "K000314",
          "K873540",
          "K903489",
          "K833012",
          "K992256",
          "K792571",
          "K181660",
          "K203378",
          "K953055",
          "K820606",
          "K003146",
          "K760167",
          "K944900",
          "K991561",
          "K842634",
          "K150044",
          "K813476",
          "K002768",
          "K153441",
          "K080299",
          "K220565",
          "K910138",
          "K781731",
          "K090829",
          "K974848",
          "K851334",
          "K792217",
          "K844963",
          "K781669"
        ],
        "registration_number": [
          "9612777",
          "2183613",
          "3012329712",
          "1220908",
          "3020460367",
          "3012494290",
          "3002808458",
          "3003799815",
          "1417592",
          "3003449582",
          "3021284283",
          "3000126629",
          "3003898360",
          "3029706818",
          "8030673",
          "3015478025",
          "3011689956",
          "3018783526",
          "2954963",
          "3043226252",
          "1526863",
          "3012542015",
          "3004365956",
          "3010272829",
          "2518422",
          "2025816",
          "9710567",
          "1317346",
          "3023272766",
          "3031506335",
          "3029871637",
          "8044169",
          "3033858988",
          "3043709871",
          "9617604",
          "1314417",
          "3030446844",
          "3011088743",
          "1024404",
          "3031233007",
          "3000143502",
          "3024987598",
          "3010683054",
          "3002797442",
          "3004748541",
          "3011137372",
          "3013557562",
          "3003767629",
          "3014579161",
          "3012970776",
          "3030447506"
        ],
        "fei_number": [
          "2183613",
          "3012329712",
          "3005747797",
          "1220908",
          "3020460367",
          "3012494290",
          "3002808458",
          "3002558692",
          "3003799815",
          "1417592",
          "3003449582",
          "3021284283",
          "3000126629",
          "3003898360",
          "3029706818",
          "3043226252",
          "3015478025",
          "3011689956",
          "3018783526",
          "1526863",
          "3012542015",
          "3004365956",
          "3010272829",
          "2518422",
          "2025816",
          "1317346",
          "3023272766",
          "3031506335",
          "3029871637",
          "3033858988",
          "3043709871",
          "1314417",
          "3004213967",
          "3030446844",
          "3001610754",
          "3011088743",
          "1024404",
          "3031233007",
          "3000143502",
          "3024987598",
          "3010683054",
          "3002797442",
          "3004748541",
          "1000283452",
          "3013557562",
          "1000142942",
          "3003767629",
          "3014579161",
          "3012970776",
          "3003256355",
          "3030447506"
        ],
        "device_name": "Spirometer, Therapeutic (Incentive)",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5690",
        "device_class": "2"
      }
    }
  ]
}