{
  "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": "25 lots; 4275 units (multiple units per lot)",
      "code_info": "Product code 900-787,  25 lots:  109010128  112030747  112052015  112062577  112093733  112114397  112114483  112125114  113015516  113025969  113036383  113047206  113057819  113068181  113078606  113099296  113099577  131110278  131110606  131210973  140111454  140211879  140312331  140412842  140513251",
      "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": "GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF  (2) BOWL UTILITY 16oz LIF  (1) TIP CAUTERY POLISHER LIF  (3) TOWELS ABSORBENT 15\" X 20\" LIF  (1) BOWL UTILITY 32oz  (1) BAG SUTURE FLORAL  (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF  (10) GAUZE SPONGES 4\" X 4\" 16PLY XRD LIF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF  (1) CAUTERY PENCIL ROCKER SWITCH LIF  (1) BLADE SURGICAL #10 STAINLESS STEEL  (1) TUBE SUCTION CO NNECTING ~\" X 12' LIF  (5) LAP SPONGE PREWASH 18\" X 18\" XRD LIF  (2) LITE GLOVES LIF  (1) DRAPE LAPAROTOMY WITH POUCH 102\" X 121\" X 78\" STD SMS  (4) DRAPE UTILITY WITH TAPE LIF  (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL  (1) BLADE SURGICAL #15 CARBON STEEL  (2) SHEET DRAPE 41\" X 69\" MEDIUM LIF  (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF    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-2351-2014",
      "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"
    }
  ]
}