{
  "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": "36 lots; 1900 units (multiple units per lot)",
      "code_info": "Product code 900-868,  36 lots:  111030667  111040921  111051390  111061692  111071970  111082114  111092560  111102783  111123143  111123300  112010206  112020509  112030750  112041359  112052020  112083060  112093955  112114402  112114485  112114583  112125119  113015518  113015570  113036769  113057511  113078350  113088896  113099297  113109649  113109878  131210844  140111254  140211858  140412476  140412909  140513484",
      "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": "UROLOGY PACK-   (2) SYRINGE 30ML SLIP TIP 1 ML LIF  (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP  (1 0) GAUZE SPONGE 4\" X 4\" 12 PLY  (1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF  (1) TABLE COVER REINFORCED 44\" X 78\" LIF  (1) DRAPE LITHO 110\" X 63\" SMS WITH LEGGINS  (3) TOWELS ABSORBENT 15\" X 20\" LIF  (1) TUR Y SET 81\"2.1m REGULAR CLAM ST.  (1) TUBE SUCTION CONNECT Y4\" X 12' LIF  (1) BAG SUTURE FLORAL    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-2355-2014",
      "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"
    }
  ]
}