{
  "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": "10 lots; 336 units (multiple units per lot)",
      "code_info": "Product code 900-1611, 10 lots:  111123361  112030624  112051849  112072779  112114640  112124965  113078268  113088833  140412455  140513000",
      "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": "RETINA PACK -   (1) TABLE COVER REINFORCED 44\" X 78\" LIF  (50) COTTON TIP APPLICATOR 6\" WOOD LIF  (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE  (2) MEDECINE CUP 2oz LIF  (5) TOWELS ABSORBENT 15\" X 20\" LIF  ( 1) UNIVERSAL EYE SHIELD  (1) EYE DRAPE  (1) BIPOLAR CABLE DISPOSABLE  ( 1) OPHTALMIC BIPOLAR PENCIL  (10) GAUZE SPONGE 4\" X 4\" 16PLY  (2) EYE PAD 2 1/8 X 2 5/8 ST.  ( 1) MAYO STAND COVER REINFORCED LIF  ( 1) KNIFE 15 5.0 CONTROLLED DEPTH.  (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF  (1) SURGICAL BLADE #15 STAINLESS STEEL  (3) SYRINGE 1CC TUBER. 25G X 5/8 SLIP TIP L/F    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-2403-2014",
      "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"
    }
  ]
}