{
  "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": [
    {
      "country": "United States",
      "city": "Fajardo",
      "address_1": "Calle Igualdad Final #7",
      "reason_for_recall": "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",
      "address_2": "",
      "product_quantity": "32 lots; 8954 units (multiple units per lot)",
      "code_info": "Product code 900-149, 32 lots:  111113165  111123349  112010052  112010280  112030621  112041077  112051768  112062421  112083062  112093900  112104147  112114637  112114952  113015429  113025941  113026204  113036749  113047333  113057861  113078258  113078600  113089192  113109733  131110083  131110399  131110578  131210961  140111409  140211872  140312328  140412830  140513345",
      "center_classification_date": "20140829",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the state of  Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.",
      "state": "PR",
      "product_description": "Customed Laparotomy Pack , convenience pack include multiple components: drape laparot., gown, absorbent towel, scrub, stck sponges/ gauzes, table cover, drape sheet, suture bag, duraprep surgical solution, cloth huck towels, utility bowls, suction tube, scalpel, Mayo Tray, Mayo Cover, & lite gloves.    EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2307-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68536",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20140520",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}