{
  "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": "31 lots/5900 units, (multiple units per lot)",
      "code_info": "Product code 900-2224, 31 lots  111030809  111040974  111051186  111051439  111061657  111123221  112010132  112020464  112030725  112041296  112083423  112093932  112114389  112114662  113015447  113025955  113026235  113036792  113057462  113067868  113078471  113088791  113099288  113109791  131110239  140111204  140211659  140312122  140312381  140412899  140513478",
      "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": "SURGICAL PACK   CONTENTS:\t  (1)   SUTURE BAG FLORAL\t  (1) WRAPPER 30\" X 30\"  (2)   UTILITY BOWL 16oz\t  (1) TRAY ORGANIZER FULL DEEP  (1)   SPECIMEN CONTAINER 4oz W/LID & LABEL\t(1)  YANKAUER SUCTION TUBE WITHOUT VENT  (5)   LAP SPONGE PREWASH 18\" X 18\" XRD\t   (1)  BLADE SURG. #15 CARBON STEEL   (2)   NEEDLE & BLADE COUNTER 1Oc MAG/CLEAR\t  (1) CAUTERY TIP POLISHER  (1)   BLADE SURG. #10 CARBON STEEL\t  (2)  LITE GLOVE  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD\t  (1) CAUTERY PENCIL ROCKER SWITCH   (1)  TIME OUT BEACON NON WOVEN ST    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-2441-2014",
      "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"
    }
  ]
}