{
  "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": "7 lots; 720 units (multiple units per lot)",
      "code_info": "Product code 900-1293, 7 lots:  110092130  111041087  112020325  112051676  112051745  112062348  112083385",
      "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": "PREMIUM OPHTHALMIC PACK- CUSTOMED-    (1) GOWN SMS X-LARGE STD RAGLAN  (1) CUP MEDICINE 2oz  (1) DRAPE OPHTHAL. WITH POUCH LIF  (1 0) SPONGE EYE SPEAR MICRO  (1) SHIELD EYE UNIVERSAL  (6) COTTON TIP APPLICATION 6\" WOOD LIF  (1 0) GAUZE SPONGES 4\"X 4\" 12PL Y  (2) TOWELS ABSORBENT 15\" x 20\" LIF  (1) COVER MAYO STAND REINFORCED LIF  (1) SYRINGE 1 ML WITHOUT NEEDLE LUER LOCK LIF  (1) COVER TABLE REINFORCED 50\" x 90\" LIF  (1) SYRINGE 3cc WITH NEEDLE 21 G X 1 % LIF  (1) GOWN LARGE SMS NON REINFORCED TOWEL/WRAP    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-2381-2014",
      "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"
    }
  ]
}