{
  "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": "29 lots; 870 units (multiple units per lot)",
      "code_info": "Product code 900-430, 29  lots:  110020453  110030667  110051146  111030671  111040897  111061672  111071814  111082217  111092389  111102877  111113116  111123253  112010174  112030874  112041411  112072872  112083431  113015513  113015697  113036365  113047211  113057626  113078328  113088864  113109841  131110304  140111229  140312164  140412467",
      "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": "CYSTO TUR PACK-  -  (1) UTILITY BOWL 32oz LIF  (1) SPECIMEN CUP WITH CAP 4oz LIF  (1 0) GAUZE SPONGE 4\" X 4\" 12PL Y LIF  (4) ABSORBENT TOWELS 15\" X 20\" LIF  (1) CYSTOSCOPY 'T' DRAPE 60\" X 87\" X 35\" SMS STD LIF  (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF  (2) LEGGINS WITH 7\" CUFF 30\" X 42\" LIF  (1) TABLE COVER REINFORCED 44\" X 78\" LIF  (1) UNDERBUTTOCK DRAPE WITH POUCH 44\" X 35\" LIF  (1) SYRINGE 60ML SLUER SLIP WITHOUT NEEDLE LIF  (1) TUR Y SET 81 \"2.1 M REGULAR CLAM  (4) GAUZE SPONGES 4\" X 4\" 12 PLY XRD 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-2325-2014",
      "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"
    }
  ]
}