{
  "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": "27 lots; 1884 units (multiple units per lot)",
      "code_info": "Product code 900-1521, 27 lots:  111102904  112041376  112041452  112062286  112104149  112114602  112124957  113015430  113015690  113025942  113026048  113036739  113046934  113047002  113047332  113057836  113078260  113088737  113088931  113089193  131110180  131110598  131210962  140211645  140211922  140412884  140513346",
      "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-   (10) GAUZE SPONGE 4\" X 4\" 16PLY   (1) TUBE SUCTION CONNECT Y.\" X12'  (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK   (1) BASIN RING  (1) TUR Y SET, 2 LEAD, ST.   (1) BAG SUTURE FLORAL  (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV   (2) TOWEL CLAMP  (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0\" x 63\" (2) SHEET DRAPE 41 \" X 58\" SMS  (1) COVER TABLE REINF 50\" X 90\"   (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX  (3) TOWELS ABSORBENT 15\" X 20\"   (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV  (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL   (1) TIME OUT BEACON NON WOVEN ST.    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-2400-2014",
      "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"
    }
  ]
}