{
  "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": "17 lots/626 units,(multiple units per lot)",
      "code_info": "Product code 900-2259, 17 lots  112083065  112114604  113015509  113025814  113036344  113046904  113056793  113057467  113067917  113078474  113088795  113099487  113109794  131110245  131210648  131211017  140211501",
      "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": "LAPAROSCOPIA COLORECTAL PACK    CONTENTS:\t  (1) \tSOLUTION SURGICAL  DURAPREP 26ml  (4) \tDRAPE UTILITY WITH TAPE  (1) \tTOWELS ABSORBENT 15\" X 20\"   (2) \t LEGGINS W/7\" CUFF 30\" X 42\"  (1) \tBLADE SURGICAL #15 STAINLESS STEEL  (1) \t BLADE SURGICAL #11 STAINLESS STEEL   (1)\tGOWN IMPERV. EXTRA REINFORCED XLG   (1)\tGOWN LGE STANDARD SMS VELCRO NECK  (1) \tIRRIGATION SUCTION TROMPET DUAL SPIKE (10)  GAUZE SPONGE 4\" X 4\" 16PLY XRD  (2) \tUTILITY BOWL 16oz  (2) \tSTERI STRIP CLOSURE  W' X 4\"  (1) \tACTIFOG W/FOAM PAD SOLUTION  (1) \tTABLE COVER REINFORCED 50\" X 90\"   (1) \tMAYO STAND COVER REINFORCED   (1)\tNEEDLE ULTRA VERES 120MM  (1) \tSTAPLE ARTICULATING ECHEL 60MM   (1) \tRELOAD  WHITE 60MM  ECHELON  (1) \tRELOAD  BLUE 60MM   ECHELON   (2) \tCANNULA  5MM XCEL SLEEVES  (1) \tTROCAR  5MM BLADELE WITH STAB SLEEVE   (1) \tTROCAR  12MM BLADELE  WITH STAB SLEEVE  (1)   DRAPE LAP. ABDO W/POUCH 102\" X 122\" X 78\" STD SMS    Product Usage:  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-2444-2014",
      "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"
    }
  ]
}