{
  "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": "2 lots; 60 units (multiple units per lot)",
      "code_info": "Product code 900-357, 2 lots:  113099550  113109831",
      "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-  (3) ABSORBENT TOWELS 15\" X 20\" LIF  (1) MAYO STAND COVER REINFORCED LIF  (1) OPHTALMIC DRAPE WITH POUCH LIF  (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF  (10) COTTON TIP APPLICATOR 6\" WOOD  (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF  (2) NEEDLE HYPODERMIC 18G X 1 Y.\"  (1) NEEDLE HYPODERMIC 25G X 5/8\"  (2) EYE PAD 2 1/8 X 2 5/8 UF  (5) EYE SPEAR MICRO SPONGE  (2) LITE GLOVE LIF  (1) CABLE BIPOLAR  (1) EYE SHIELD UNIVERSAL  (1) OPHTALMIC PENCIL BIPOLAR  (1) IV ADM. SET 15 DROPS 106\" LONG L/F  (1) TABLE COVER REINFORCED 50\" X 90\" UF  (1) KNIFE/BLADE MIN. EDGE ROUND  (1) KNIFE 15 5.0 CONTROLLED  (1) PLASTIC TRAY 3/COMPARTMENT  (1)KNIFE 3.2MM ANGLE BEVEL UP  (1) CYSTOTOMO IRRIG. 25GA X5/8  (1) MAYO TRAY LARGE  (2) GOWN STANDARD LARGE SMS STD VELCRO NECK  (1) PVP PAINT 8\" STICK SPONGE  (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF    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-2318-2014",
      "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"
    }
  ]
}