{
  "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; 1771 units (multiple units per lot)",
      "code_info": "Product code 900-1482, 39 lots:  110102428  110112608  110123088  111010049  111020265  111030581  111040888  111051317  111061497  111071865  111082190  111092354  111102683  111113009  111123347  112010050  112020371  112030620  112041188  112051766  112062419  112083396  112093898  112124950  112125282  113025940  113036669  113047197  113067888  113068256  113078256  113109732  131210747  140111083  140211641  140312070  140312453  140513090  140613609",
      "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": "E..N.T. PACK -   (5) SPONGE TONSIL 7/8 XRD  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) MAYO STAND COVER REINFORCED L/F  (1) TUBE SUCTION CONNECT %\" X 12' L/F  (1) CAUTERY TIP POLISHER LIF  (1) SUTURE BAG FLORAL  (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL  (1) CAUTERY PENCIL HAND SWITCHING  (2) ABSORBENT TOWELS 15\" X 20\" L/F  (1) DRAPE SHEET 41 \" X 58\" SMS L/F  (1) EAR/ULCER SYRINGE 2oz LIF  (2) MEDICINE CUP 2oz  (1 0) GAUZE SPONGE 4\" X 4\" 16PL Y  (1) *Pr. SURGICAL GLOVES #7% POWDER  (1) *Pr. SURGICAL GLOVES #7 POWDER  (9) LABEL FOR SKIN MARKER    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-2395-2014",
      "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"
    }
  ]
}