{
  "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": "37 lots; 858 units (multiple units per lot)",
      "code_info": "Product code 900-752,  37 lots:  109020288  109040862  109051218  109081882  109112704  110010111  110020448  110041015  110061538  110071775  110081984  110122945  111010161  111020378  111030658  111040919  111051388  111061566  111071943  111082111  111092403  111092464  111102780  111123294  112020512  112030745  112093950  112124705  112125113  113036768  113078345  113088889  113099454  113099588  113109872  120141354  131110277",
      "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": "NEURO PACK-   (1)TABLE COVER 44\" x 90\"  (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP  (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS  (1) BAG SUTURE FLORAL  (1) MAYO STAND COVER REINFORCED LIF  (2) TOWELS ABSORBENT 15\" X 20\" LIF  (4) DRAPE UTILITY WITH TAPE LIF  (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT  (1) STOCKINETTE IMPERVIOUS 14\" X 48\" L/F  (1) SHEET SPLIT WITH ADHESIVE 1 08\" X 77\" STD SMS LIF  (1) TOP DRAPE WITH ADHESIVE 1 08\" X 50\" STD 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-2350-2014",
      "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"
    }
  ]
}