{
  "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": "12 lots; 1775 units (multiple units per lot)",
      "code_info": "Product code 900-1156, 12 lots:  109122834  110010026  110020379  110020559  110040869  110041086  110051182  110061483  110071624  110081995  110092119  110102582",
      "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": "PHACO PACK -   (10) GAUZE SPONGE 4\" X 4\" 12PLY   (2) SYRINGE 3cc W/NDL. 21G X 1 %\"  (2) MEDICINE CUP 2 oz.   (1) OPHTHALMIC DRAPE W/POUCH  (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS  (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44\" X 90\"  (1) MAYO STAND COVER REINF. LIF (3) ABSORBENT TOWEL 15\" x 20 LIF  (2) EYE PAD 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR MICRO SPONGE VELCRO/NECK    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-2376-2014",
      "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"
    }
  ]
}