{
  "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": "1 lot/ 76 units",
      "code_info": "Code 900-2940, 1 lot",
      "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": "Obstetrical Surgical pack,   code 900-2940, contains:  (1) BLANKET RECEIVING 100 COTTON  (3) TOWEL ABSORBENT 15 X 20 LIF  (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF  (1) SYRINGE EAR/ULCER 2oz. LIF  (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF  (2) LEGGINS W/7'' CUFF 30X42 L/F  (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF  (1) OB PAD WRAP OVERNIGHT  (1) TABLE COVER REINFORCED 50X90 LIF  (1) DRAPE UNDERBUTTOCK W/POUCH 44X35\"  (1) CLAMP UMBILICAL CORD LIF  (1) BOWL PLASTIC 80oz. LIF  (1) LID FOR BOWL 80oz. CLEAR LIF  (1) BEANNIES BABY  (5) LAP SPONGE PREWASH 18X18XRD  (1) MAYO TRAY SMALL  (1) DRAPE SHEET 41X58 SMS LIF  (1) UNDERPAD 36X36 BEIGE  (1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON  (10) GAUZE SPONGE 4X4 16PLY 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-2513-2014",
      "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"
    }
  ]
}