{
  "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": "63 lots; 20094 units (multiple units per lot)",
      "code_info": "Product code 900-944, 63 lots:  110010120  110010151  110020418  110020489  110020494  110040959  110040961  110041046  110041047  110061499  110061544  110071716  110071717  110071807  110071808  110092290  110092318  110092409  110092412  110112786  110112787  110122904  110122905  111010173  111010179  111020306  111030826  111040980  111051219  111061648  111071971  111082117  111092408  111102641  111102787  111123307  112010211  112020471  112030755  112030944  112041363  112052025  112062574  112083442  112104089  112114686  113025972  113036598  113047119  113047149  113057515  113057821  113068182  113078576  113099299  113099580  131210848  131210975  140111456  140211881  140312387  140412843  140513353",
      "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": "CATARACT PACK- OJOS INC.-   (1) TABLE COVER REINF. 44\" X 78\" L/F   (2) MEDICINE CUP 1oz.  (2) ABSORBENT TOWEL 15\" X 20\" LIF   (1 0) EYE SPEAR MICRO SPONGE  (1) EYE PAD 2 1/8 X 2 5/8 LIF   (4) DRAPE UTILITY LIF  (1) EYE SHIELD UNIVERSAL   (2) GOWN LGE STANDARD SMS VELCRO/NECK  (1) MAYO STAND COVER REINF. LIF  (1) EYE DRAPE LIF  (1) SYRINGE 3cc W/0 NDL L/LOCK LIF   (1) WIPE INSTRUMENT 1MM 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-2361-2014",
      "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"
    }
  ]
}