{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "122369",
      "product_res_number": "Z-0128-2014",
      "event_date_initiated": "2013-10-01",
      "event_date_posted": "2013-11-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-01-21",
      "res_event_number": "66423",
      "product_code": "EWL",
      "k_numbers": [
        "K821568"
      ],
      "product_description": "Blom-Singer Adjustable Tracheostoma Valve II\nModels: BE8025H and BE8025H-R3",
      "code_info": "LOTS: 1057760, 1057919 and 1059222",
      "firm_fei_number": "2025182",
      "recalling_firm": "Helix Medical LLC",
      "address_1": "1110 Mark Ave",
      "city": "Carpinteria",
      "state": "CA",
      "postal_code": "93013-2918",
      "additional_info_contact": "Dr. Mark Ostwald\n805-576-5428",
      "reason_for_recall": "InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging.  The ATSV II Valve product cannot be used as intended without the product body.",
      "root_cause_description": "Packaging change control",
      "action": "A phone script and a customer notification letter are provided.  The recall was initiated on 10/1/13 and customers will be notified that InHealth Technologies, a division of Helix Medical, LLC has initiated a recall of the following 3 lots of the Blom-Singer Adjustable Tracheostoma Valve (BE8025H and BE8025H-R3): 1057760, 1057919 and 1059222.  The phone script provides the problem identified and the actions to be taken.  Customers are instructed to complete the Customer response form and return by email to belinda.jackson@helixmedical.com, fax to (805) 566-5381 or by mail to InHealth Technologies, 1110 Mark Avenue, Carpinteria, CA 93013.  Customers are also instructed to Contact UPS at 1-800-742-5877 and provide In Health Technologies UPS account no., 846718. UPS will come to your site, package the recalled product(s) and ship it to InHealth Technologies at InHealth Technologies expense.  Customers are instructed to respond within 10 days.",
      "product_quantity": "47 units",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  Belgium, Canada, Croatia, Germany, Ireland, and Italy.",
      "openfda": {
        "k_number": [
          "K141380",
          "K812982",
          "K971244",
          "K940638",
          "K043138",
          "K240763",
          "K090455",
          "K082206",
          "K915761",
          "K920090",
          "K945288",
          "K092593",
          "K991587",
          "K974132",
          "K854112",
          "K912486",
          "K832852",
          "K881011",
          "K854118",
          "K900518",
          "K932120",
          "K820737",
          "K800563",
          "K853940",
          "K832967",
          "K810020",
          "K871885",
          "K861088",
          "K932163",
          "K093258",
          "K930105",
          "K902112",
          "K022125",
          "K812864",
          "K842896",
          "K904729",
          "K945287",
          "K821568",
          "K823749",
          "K131947"
        ],
        "device_name": "Prosthesis, Laryngeal (Taub)",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3730",
        "device_class": "2",
        "registration_number": [
          "2029275",
          "2025182",
          "3013188547",
          "8032044",
          "2011171"
        ],
        "fei_number": [
          "3002806269",
          "1000306431",
          "2025182",
          "3013188547",
          "2011171"
        ]
      }
    }
  ]
}