{
  "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-2599-2024",
      "product_description": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30;   c)\tPAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55",
      "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 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers:   3868288, 3901288, 3917984, 3942491, 3952376, 3988093, 4015545, 4075235, 4086043, 4196278, 4216321, 4335004, 4348474;  b) UDI/DI15021312005844, Product Code/List Number/Item Code 60PFS30, Lot Numbers:  3853454, 3868300, 3871052, 3884251, 3907992, 3939630, 3952417, 3955789, 3962601, 3965922, 3982669, 3982670, 3991157, 4005649, 4005650, 4018519, 4029510, 4035742, 4048015, 4051632, 4066295, 4077078, 4080801, 4086025, 4092648, 4097834, 4110453, 4119110, 4131005, 4136139, 4148028, 4159992, 4171551, 4176201, 4180492, 4185419, 4201383, 4206818, 4216322, 4221344, 4273425, 4276465, 4283239, 4292166, 4335005, 4345011, 4351239, 4374438, 4374439, 4374440, 4381017, 4383626, 4388167, 4388168, 4389899, 4393409, 4399180, 4400668;  c) UDI/DI 15021312005851, Product Code/List Number/Item Code 60PFS35, Lot Numbers:  3840084, 3843107, 3853456, 3853457, 3853458, 3858172, 3868320, 3874291, 3874292, 3874293, 3874294, 3880702, 3884241, 3887745, 3891532, 3901293, 3904667, 3907987, 3917981, 3920937, 3920938, 3930041, 3936575, 3942465, 3942466, 3942467, 3942468, 3946228, 3946229, 3946230, 3946231, 3955802, 3962598, 3962599, 3982671, 3982672, 3988094, 3988095, 3988096, 3988097, 3991159, 3991160, 3991161, 3991162, 4005651, 4005654, 4008218, 4008219, 4015546, 4015547, 4021418, 4026694, 4033724, 4035743, 4048010, 4051625, 4053720, 4056230, 4060212, 4060213, 4063185, 4071981, 4075241, 4083914, 4089301, 4092633, 4097833, 4105259, 4107594, 4110454, 4116094, 4122438, 4128018, 4130990, 4134027, 4145710, 4148001, 4151036, 4153618, 4156615, 4159944, 4163822, 4163823, 4176221, 4179357, 4185420, 4196279, 4197615, 4201384, 4204817, 4206819, 4209565, 4216323, 4217444, 4218707, 4221345, 4223730, 4231501, 4233963, 4233964, 4240150, 4254247, 4260068, 4273426, 4279333, 4283240, 4286802, 4289480, 4292167, 4292168, 4331613, 4331614, 4335008, 4335009, 4335010, 4335011, 4345012, 4352785, 4352786, 4360406, 4360407, 4360408, 4369596, 4369598, 4374441, 4374442, 4374443, 4381018, 4381019, 4381020, 4383627, 4383628, 4383632, 4388169, 4388170, 4388171, 4388172, 4393410;  d) UDI/DI 15021312005868, Product Code/List Number/Item Code 60PFS40, Lot Numbers:  3835740, 3868304, 3868305, 3868306, 3868307, 3868309, 3868310, 3868311, 3871061, 3880721, 3880722, 3884259, 3887731, 3894886, 3894887, 3897887, 3901308, 3907996, 3907997, 3918003, 3920955, 3942503, 3942504, 3942505, 3942506, 3946268, 3946269, 3946270, 3955782, 3955783, 3955784, 3955785, 3959304, 3959305, 3962576, 3982674, 3982679, 3982680, 3982683, 3988100, 3988101, 3988102, 3991164, 3991165, 3991166, 3991167, 3991168, 4005655, 4005656, 4005662, 4005664, 4005665, 4005666, 4015548, 4015549, 4015550, 4033725, 4048022, 4051650, 4051651, 4053718, 4056236, 4056237, 4063186, 4063187, 4071985, 4071986, 4075242, 4077110, 4080791, 4089309, 4093736, 4107572, 4107573, 4113115, 4119101, 4122448, 4128031, 4139013, 4145719, 4151013, 4153596, 4159975, 4161991, 4163834, 4171552, 4176239, 4179358, 4180464, 4185421, 4185422, 4185423, 4204818, 4206820, 4209566, 4209567, 4212780, 4216324, 4218708, 4221346, 4231502, 4233965, 4233967, 4234639, 4237385, 4240151, 4254248, 4260069, 4273427, 4279334, 4283241, 4286803, 4286804, 4289481, 4289482, 4292169, 4292170, 4322675, 4331615, 4335012, 4335013, 4335014, 4345013, 4345014, 4348476, 4348477, 4351240, 4355431, 4355432, 4357235, 4357236, 4357237, 4358510, 4365777, 4369600, 4379950, 4379960, 4381021, 4383629, 4383630, 4383631, 4388173, 4388174, 4388175, 4389901, 4389902, 4399188;  e) UDI/DI 15021312005875, Product Code/List Number/Item Code 60PFS45, Lot Numbers:  3843109, 3853462, 3868224, 3871045, 3877666, 3884240, 3887744, 3894868, 3901292, 3907986, 3920936, 3923717, 3931141, 3939634, 3942458, 3942459, 3942460, 3949039, 3955799, 3955800, 3955801, 3962597, 3982681, 3982682, 3988103, 3988104, 3988105, 3988106, 3991169, 3991170, 3991171, 3991172, 4015552, 4015553, 4015556, 4015557, 4018520, 4033726, 4035745, 4051624, 4053731, 4060211, 4071980, 4083912, 4093737, 4105258, 4107600, 4113105, 4122436, 4136141, 4148002, 4156616, 4163820, 4179359, 4185424, 4196280, 4197617, 4209568, 4212781, 4216325, 4217445, 4223731, 4231504, 4237386, 4240152, 4254249, 4276466, 4279335, 4283242, 4289483, 4289484, 4292172, 4322676, 4335015, 4335016, 4345015, 4347208, 4351241, 4353064, 4353095, 4374444, 4374445, 4374446, 4379941, 4381022, 4383633, 4383634, 4388176, 4388177, 4388178, 4388179, 4389903, 4395789;  f) UDI/DI 15021312005882, Product Code/List Number/Item Code 60PFS50, Lot Numbers:  3840085, 3868297, 3868298, 3868299, 3877642, 3884250, 3894889, 3897872, 3911431, 3920969, 3939629, 3942455, 3946245, 3949028, 3955787, 3955788, 3962600, 3982684, 3988108, 3988109, 3988110, 3991174, 3991175, 3991176, 3997817, 3997828, 4015558, 4018521, 4018522, 4029511, 4051631, 4060227, 4071969, 4083931, 4096826, 4100896, 4110455, 4122443, 4128043, 4145694, 4153587, 4159976, 4168142, 4171553, 4180498, 4204819, 4206821, 4212782, 4217446, 4218709, 4221347, 4233968, 4254252, 4279336, 4283243, 4286805, 4289485, 4292173, 4335017, 4335018, 4345016, 4345017, 4352788, 4365778, 4366203, 4369601, 4369602, 4374447, 4374448, 4381023, 4383635, 4388180, 4388181, 4389904, 4395790, 4399191;  g) UDI/DI 15021312005899, Product Code/List Number/Item Code 60PFS55, Lot Numbers:  3853464, 3868208, 3868209, 3877656, 3877657, 3884235, 3901309, 3911422, 3930034, 3930035, 3930036, 3930037, 3936573, 3939625, 3950394, 3982685, 3988111, 3988112, 3991177, 3991178, 3991179, 3997818, 3997829, 4033727, 4035746, 4053735, 4063188, 4083938, 4105250, 4110456, 4122426, 4128035, 4148016, 4163837, 4179360, 4180173, 4204820, 4209569, 4233969, 4276467, 4283244, 4289486, 4322677, 4335020, 4335021, 4352789, 4362868, 4369603, 4369604, 4374449, 4383636, 4388182, 4389905, 4395791, 4399192",
      "more_code_info": ""
    }
  ]
}