{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94852",
      "recalling_firm": "Smiths Medical ASD Inc.",
      "address_1": "6000 Nathan Ln N",
      "address_2": "",
      "postal_code": "55442-1690",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.",
      "recall_number": "Z-2605-2024",
      "product_description": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025;   3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030;   3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN035;   4.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN040;   2.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP025;   3.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP030;   3.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP035;   4.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP040;   4.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP045;   5.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP050;   5.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SP055",
      "product_quantity": "",
      "reason_for_recall": "Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.",
      "recall_initiation_date": "20240529",
      "center_classification_date": "20240823",
      "report_date": "20240904",
      "code_info": "a) UDI/DI 15021312000016, Product Code/List Number/Item Code 65SN025, Lot Numbers:   4060220, 4119090, 4180463, 4201335, 4204802, 4374400, 4393388;  b) UDI/DI 15021312000030, Product Code/List Number/Item Code 65SN030, Lot Numbers:  3965331, 4119093, 4139005, 4163833, 4171566, 4267838, 4351231, 4399123;  c) UDI/DI 15021312000061, Product Code/List Number/Item Code 65SN035, Lot Numbers:  3942499, 4033697, 4048018, 4060226, 4107576, 4119094, 4134009, 4156653, 4168191, 4171567, 4197599, 4213396, 4221326, 4334871, 4348390;  d) UDI/DI 15021312000085, Product Code/List Number/Item Code 65SN040, Lot Numbers:  4043945, 4068907, 4075245, 4204803, 4216297, 4218689, 4254207, 4328206;  e) UDI/DI 15021312000276, Product Code/List Number/Item Code 65SP025, Lot Numbers:  4016047, 4016048, 4213398, 4221327,15021312000276,  4344963, 4348391, 4388093, 4389864;  f) UDI/DI 15021312000283, Product Code/List Number/Item Code 65SP030, Lot Numbers:  4035682, 4077097, 4086010, 4116097, 4138989, 4171568, 4173719, 4180488, 4185398, 4197601, 4221329, 4254212, 4331544, 4334872, 4348392;  g) UDI/DI 15021312000290, Product Code/List Number/Item Code 65SP035, Lot Numbers:  3868192, 3952355, 4011353, 4033698, 4035683, 4060200, 4075234, 4116087, 4128012, 4139008, 4142433, 4159990, 4171569, 4180459, 4201336, 4204804, 4218690, 4292151, 4344966, 4348395, 4362879, 4380067, 4388094, 4389865;  h) UDI/DI 15021312000306, Product Code/List Number/Item Code 65SP040, Lot Numbers:  3897869, 3917985, 4011354, 4035684, 4056234, 4097821, 4113108, 4128027, 4138996, 4153578, 4163825, 4168174, 4185399, 4221330, 4237345, 4334873, 4348396, 4348397, 4358513, 4369534;  i) UDI/DI 15021312000313, Product Code/List Number/Item Code 65SP045, Lot Numbers:  3955777, 3997788, 4035685, 4097822, 4113119, 4122433, 4138986, 4173720, 4240121, 4334874, 4348399, 4388095, 4399124;  j) UDI/DI 15021312000320, Product Code/List Number/Item Code 65SP050, Lot Numbers:  3868214, 3936579, 3952367, 3987924, 3997789, 4029490, 4034958, 4085999, 4095921, 4107590, 4116090, 4122453, 4134016, 4139012, 4159941, 4171570, 4180460, 4197603, 4267839, 4351232, 4352754, 4383592, 4388096, 4389866, 4399125;  k) UDI/DI 15021312000337, Product Code/List Number/Item Code 65SP055, Lot Numbers:  3897865, 3952418, 3987925, 4005582, 4105263, 4113111, 4159977, 4173722, 4204805, 4328207, 4334875, 4348403, 4353066",
      "more_code_info": ""
    }
  ]
}