{
  "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": "2 lots/ 112 units, multiple units per lot",
      "code_info": "900-2654, 2 lots:  112062214  112093599",
      "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": "Face Pack MRT, product code 900-2654, contains:  (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF  (2) TOWELS ABSORBENT 15 X 20 LIF  (1) DRAPE INST. MAGNETIC 10 X 16 LIF  (1) TRAY HALF DEEP  (1) COVER MAYO STAND REINFORCED LIF  (1) SHEET ENT SPLIT 110 X 77 SMS LIF  (1) COVER TABLE REINFORCED 44\" X 78\" LIF  (20) GAUZE SPONGES 4 X 4 12PLY L/F  (6) TOWELS CLOTH HUCK C BLUE L/F  (2) TIP ABSORB. APPLIC STICK SPONGE LIF  (1) STRIP STERI CLOSURE LIF  (1) CUP DENTURE 8oz. TEAL WITH LID  (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF  (2) SYRINGE 10ML DARK GREEN  (1) SYRINGE 10ML YELLOW L/F  (1) LITE GLOVE LIF  (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF  Product Usage:  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-2488-2014",
      "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"
    }
  ]
}