{
  "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": "24 lots; 2564 units (multiple units per lot)",
      "code_info": "Product code 900-410,  24 lots:  112020166  112020534  112030841  112041322  112051983  112062488  112072871  112083430  112093939  112114673  112125090  113025992  113036358  113036764  113078476  113078814  113099291  113099573  131110300  140111223  140211668  140312159  140412838  140513349",
      "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": "CESAREAN PACK -  -   (1) MAYO STAND COVER REINFORCED LIF  (20) LAP SPONGES PRE-WASH XRD LIF  (1) UMBILICAL CORD CLAMP LIF  (1) COVER TABLE REINFORCED 50\" X 90\" LIF  (1) SURGICAL DURAPREP SOLUTION 26ML LIF  (1) BEANNIES BABY  (1) POLISHER TIP CAUTERY LIF  (1) LITE GLOVE L/F  (1) CAUTERY PENCIL ROCKER SWITCH L/F  (1) C-SECTION DRAPE WITH POUCH LIF  (1) MAYO TRAY SMALL  (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F  (1) BLADE SURGICAL #10 CARBON STEEL  (2) BOWL UTILITY 32oz. LIF  (2) PAD OBSTETRICAL X- LARGE LIF  (5) TOWEL ABSORBENT 15\" X 20\" LIF  (1) DRAPE SHEET 41\" X 58\" SMS LIF  (1) TUBE SUCTION CONNECT. Y..\" X 12' LIF  (1) EAR ULCER SYRINGE 2oz. LIF  (2) GOWM IMPERVIOUS EXTRA REINFORCED X-LARGE  (1) RECEIVING BLANKET 100% COTTON  (2) NEEDLE & BLADE COUNTER 1 Oc 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-2322-2014",
      "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"
    }
  ]
}