{
  "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-2604-2024",
      "product_description": "PORTEX Bivona Tracheostomy Silicone Tube, labeled as:    a)\tPAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025;   b)\tPAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030;   c)\tPAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035;   d)\tPAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040;   e)\tPAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045;   f)\tPAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050;   g)\tPAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;",
      "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 15021312005943, Product Code/List Number/Item Code 65P025, Lot Codes:   3897888, 3981971, 4016049, 4334862, 4374393, 4380064, 4393387, 4400619;  b) UDI/DI 15021312005950, Product Code/List Number/Item Code 65P030, Lot Codes:  3880701, 3904666, 3923718, 3926981, 3930042, 4171565, 4196257, 4221324, 4331542, 4334863, 4348379, 4374394, 4388089;  c) UDI/DI 15021312005967, Product Code/List Number/Item Code 65P035, Lot Codes:  3864229, 3908001, 3920948, 3923722, 3931150, 3942487, 3955807, 4035680, 4056227, 4086031, 4119112, 4142431, 4147993, 4237343, 4331543, 4334864, 4348380, 4348382, 4369540, 4380065, 4395735;  d) UDI/DI 15021312005974, Product Code/List Number/Item Code 65P040, Lot Codes:  3853369, 3868319, 3887746, 3904668, 3942471, 3950391, 3952347, 3965907, 4116095, 4145712, 4153617, 4213393, 4237344, 4289465, 4334865, 4348383, 4348384, 4348385, 4374395, 4383591;  e) UDI/DI 15021312005981, Product Code/List Number/Item Code 65P045, Lot Codes:  3868312, 3871060, 3904681, 3904682, 3933472, 4080790, 4089308, 4107571, 4131006, 4145718, 4153595, 4161990, 4204801, 4216296, 4292150, 4334866, 4344346, 4348387, 4374396, 4380066, 4400620;  f) UDI/DI 15021312005998, Product Code/List Number/Item Code 65P050, Lot Codes:   3868226, 3871030, 3871031, 3911435, 3930040, 3942493, 3955805, 4015525, 4092637, 4110429, 4139011, 4163824, 4179335, 4213394, 4221325, 4289466, 4328204, 4334867, 4351222, 4369532, 4369533, 4380991, 4388090,  g) UDI/DI 15021312006001, Product Code/List Number/Item Code 65P055, Lot Codes:  3840082, 3871043, 3871044, 3901291, 3926980, 3942462, 3942463, 3952341, 3959335, 4011352, 4035681, 4056231, 4077094, 4083913, 4100882, 4107599, 4119123, 4134024, 4138988, 4153615, 4159942, 4168155, 4173721, 4180495, 4195801, 4213395, 4218688, 4267837, 4334869, 4344349, 4351229, 4351230, 4353075, 4389862, 4389863, 4400621",
      "more_code_info": ""
    }
  ]
}