{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ashland",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "74856",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "28 Howe St",
      "address_2": "N/A",
      "postal_code": "01721-1305",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide  Foreign: Canada, Latin America",
      "recall_number": "Z-2706-2016",
      "product_description": "Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing  as follows:      This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time use for periods up to 6 hours, after which it must be discarded in a manner which is within applicable laws and practices. Terumo Cardiovascular System Cardiovascular Procedure Kits. Each kit is assigned a unique product code/catalog number that is specific to the consignee who has established specifications for the kit.        US Product Codes:  72021                      72358                      71180-01                   76021                      76022                      76023                      76024                      76025                      71801-01                   71801-01                   71801-01                   71801-01                   71801-01                   74163-03                   71296-01                   74460-01                   74460-01                   74460-01                   73208-03                   74382-01                   74382-01                   74382-01                   74916                      74916                      74916                      70089-07                   74063-01                   74063-01                   74460-01                   74460-01                   74460-01                   74460-01                   75252-01                   74951                      75881                      74271-01                   71085-02                   72742                      75314                      75368                      75368                      76095                      76095                      73339-01                   73789                      74417                      72204                      72965-03                   73644                      73645-01                   73700                      73861                      73871                      73901-03                   75612                      75617                      75986                      76095                      73645-01                   73645-01                   70099-04                   75544                      75272                      75674                      75674                      73180                      73180                      73180                      75437                      75674                      75274                      73811                      73811                      74915                      71175-03                   73738                      76117                      75129                      75642                      75642                      72596                      72596                      72596                      75179                      74980-01                   8340TXC-07                 8340TXC-07                 8340TXC-07                 71875-01                   74235-01                   74476                      75059                      75547                      75547                      74235-01                   8351TXC-01                 73124                      73281-01                   73282-01                   73874                      74477                      8340TXC-07                 76069                      76070                      76071                      76072                      74737                      73933                      73933                      73933                      73933                      73933                      73933                      71608-04                   75413                      74959                      75472                      75472                      75449                      75923                      75923                      73729-01                   73730-01                   74046-",
      "product_quantity": "2207 kits",
      "reason_for_recall": "Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated",
      "recall_initiation_date": "20160725",
      "center_classification_date": "20160831",
      "termination_date": "20190820",
      "report_date": "20160907",
      "code_info": "US Lot Codes:  UG06                            UE18R                           UF31                            UF31A                           UF31T                                        UG13                            UG13A                           UG20                            UG20T                           UG27                            UG27T      OUS Lot Codes:                     UG13                            UG13T                           UG20                            UG20T"
    }
  ]
}