{
  "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": "22 lots; 1485 units (multiple units per lot)",
      "code_info": "Product code 900-254, 22 lots:  111113093  111123230  112030815  112041318  112051972  112093935  112114665  113026059  113026113  113036348  113036461  113047019  113047218  113057472  113088799  113089161  113109797  131110249  131210793  140312134  140412465  140412904",
      "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": "0.B. PACK -  HSCH-   (1) PVP SCRUB 8\" STICK SPONGES  (1) UNDERBUTTOCK DRAPE WITH POUCH  (2) LEGGINS WITH 7\" CUFF 30\" X 42\"  (1) ABDOMINAL DRAPE WITH TAPE LIF  (1) SPONGE LAP PREWASH 18\" X 18\" XRD LIF  (1) BOWL PLASTIC WITH LID 80oz LIF  (1) RECEIVING BLANKET 100% COTTON  (1) BABY BLANKET IMPERVIOUS POLY ABS. LIF  (1) UMBILICAL CORD CLAMP  (3) ABSORBENT TOWELS 15\" X 20\" LIF  (1) UTILITY BOWL 16oz LIF  (2) TRAY ORGANIZER FULL DEEP  (3) ABSORBENT TIP APPLICATOR  (2) GLOVE EXAM MEDIUM  (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP  (10) GAUZE SPONGE 4\" X 4\" 12PLY  (2) PAD OBSTETRICAL X-LARGE ST. LIF  (1) EAR ULCER SYRINGE 2oz UF  (1) BABY BEANNIES  (2) DRAPE SHEET 41 \" X 58\" SMS  (1) SCISSORS UMBILICAL  (1) TABLE COVER REINFORCED 44\" X 78\" L/F  (2) WRAPPER 24\" X 24\" LI    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-2314-2014",
      "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"
    }
  ]
}