{
  "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": "39 lots; 1712 units (multiple units per lot)",
      "code_info": "Product code 900-486, 39  lots:  109102328  109112574  109122809  110010090  110020385  110030671  110030811  110051245  110071697  110102446  110112662  111010131  111020373  111030681  111041112  111113120  111123259  111123435  112020536  112030844  112051987  112093629  112114394  112114481  112114571  113015453  113025988  113036367  113057489  113067929  113099436  113109846  131110263  131210820  140111233  140312167  140412470  140412907  140513249",
      "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": "LAPAROSCOPY PACK -  -  (1) MAYO STAND COVER REINFORCED LIF  (2) DRAPE % ECONOMY 53\" X 77\" LIF  (1) TUBE SUCTION CONNECT. v.i\" X 12' LIF  (1) SCALPEL WITH HANDLE #11  (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02\" X 122\" X 78\" LIF  (1 0) GAUZE SPONGE 4\" X 4\" 16 PLY XRD LIF  (8) TOWEL ABSORBENT 15\" X 20\" L/F  (1) TABLE COVER REINFORCED 50\" X 90\" L/F  (1) *LAPAROSCOPIC WOUND CLOSURE LATEX  (1) DRAPE LASER CAMERA WITH/EL 6\" X 96\" LIF  (4) DRAPE UTILITY WITH TAPE L/F  (3) GOWN IMPERVIOUS REINFORCED X-LARGE SMS L/F    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-2329-2014",
      "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"
    }
  ]
}