{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "221228",
      "product_res_number": "Z-2909-2026",
      "event_date_initiated": "2026-06-17",
      "event_date_posted": "2026-08-06",
      "recall_status": "Open, Classified",
      "res_event_number": "99299",
      "product_code": "EWL",
      "k_numbers": [
        "K932120"
      ],
      "product_description": "Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm\nREF: 1610-LEF",
      "code_info": "Lot #0000369233/UDI: 00813307014133",
      "firm_fei_number": "2025182",
      "recalling_firm": "Freudenberg Medical, LLC",
      "address_1": "1110 Mark Ave",
      "city": "Carpinteria",
      "state": "CA",
      "postal_code": "93013-2918",
      "additional_info_contact": "Ms. Rhonda M. Kops\n805-684-3304",
      "reason_for_recall": "Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.",
      "root_cause_description": "Labeling mix-ups",
      "action": "On June 26, 2026, Inhealth Technologies issued a Urgent Medical Device Recall Notification  via FedEx to affected consignees. Inhealth ask consignees to take the following actions:\n\n1. Do not use, ship, or distribute affected products\n2. Identify and isolate all affected inventory\n3. Destroy all affected devices\n4. Complete the attached response form\n5. Return confirmation no later than: July 8, 2026\n6.  Email confirmation of product destruction to: regulatoryaffairs@freudenbergmedical.com",
      "product_quantity": "12 units",
      "distribution_pattern": "US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.",
      "openfda": {
        "k_number": [
          "K861088",
          "K832852",
          "K043138",
          "K920090",
          "K022125",
          "K092593",
          "K854118",
          "K932163",
          "K082206",
          "K832967",
          "K912486",
          "K932120",
          "K902112",
          "K853940",
          "K940638",
          "K945288",
          "K810020",
          "K904729",
          "K131947",
          "K945287",
          "K971244",
          "K842896",
          "K854112",
          "K812982",
          "K090455",
          "K093258",
          "K821568",
          "K812864",
          "K823749",
          "K915761",
          "K141380",
          "K800563",
          "K900518",
          "K930105",
          "K820737",
          "K881011",
          "K240763",
          "K974132",
          "K991587",
          "K871885"
        ],
        "registration_number": [
          "8032044",
          "2029275",
          "2025182",
          "3013188547",
          "2011171"
        ],
        "fei_number": [
          "2025182",
          "1000306431",
          "3013188547",
          "3002806269",
          "2011171"
        ],
        "device_name": "Prosthesis, Laryngeal (Taub)",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3730",
        "device_class": "2"
      }
    }
  ]
}