{
  "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": "20 lots; 1812 units (multiple units per lot)",
      "code_info": "Product code 900-1933, 20  lots:  112114613  112125046  113015506  113025815  113036476  113046936  113047008  113057440  113057613  113057842  113078288  113078581  113089021  113099282  113109641  131110072  131110603  131210966  140412831  140513465",
      "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": "OPHTALMIC PACK-   (1) TABLE COVER REINF. 44\" X 78\" UF   (1) GOWN SMS XLGE STD UF  (2) TOWEL ABSORBENT 15\" X 20\" LIF   (1) SYRINGE 3cc W/0 NDL LILOCK UF  (1) MAYO STAND COVER REINF. LIF   (1) NEEDLE HYPODERMIC 18G X 1% ST. UF  (10) EYE MICRO SPONGE UF   (2) LABEL CONTRAST BLUE  (1) GOWN LGE STD SMS   (1) WIPE INSTRUMENT 1MM  (1) EYE DRAPE UF   (1) LABEL XYLOCAINE FOR MEDICATION YELLOW  (1) IODINE POVIDONE 1oz.   (1) EYE SHIELD UNIVERSAL L/F  (10) APPLICATOR COTION 6\" WOOD   (1) BALANCED SALT SOLUTION 18ML LIF  (10) GAUZE SPONGE 4\" X 4\" 12P Y UF   (1) LABEL BSS  (1) TRAY 3/COMPARTMENT LIF   (1) LABEL EPINEPHRINE VIOLET/WHITE  (1) LABEL IODINE WHITE/BLACK      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-2420-2014",
      "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"
    }
  ]
}