{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Carpinteria",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62970",
      "recalling_firm": "Helix Medical LLC",
      "address_1": "1110 Mark Ave",
      "address_2": "N/A",
      "postal_code": "93013-2918",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom",
      "recall_number": "Z-2336-2012",
      "product_description": "BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO    The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.",
      "product_quantity": "2 devices",
      "reason_for_recall": "Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.",
      "recall_initiation_date": "20120308",
      "center_classification_date": "20120907",
      "termination_date": "20130402",
      "report_date": "20120919",
      "code_info": "Lot#1008419"
    }
  ]
}