{
  "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 differ 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": "11 lots; 681 units (multiple units per lots)",
      "code_info": "Product code 900-2004, 11 lots:  112030703  112061278  112114387  112114491  112114877  113068160  113078570  113089022  113099283  131110222  140613472",
      "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": "LAPAROSCOPY CHOLE PACK -   (6) TOWELS ABSORBENT 15\" X 20\" LIF  (1) MAYO STAND COVER REINFORCED L/F  (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF  (1) SURGICAL BLADE #11 CARBON STEEL  (1) TUR Y SET, 2LEAD L/F  (4) DRAPE UTILITY WITH TAPE LIF  (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT)  (1) ULTRA VERES NEEDLE 120mm  (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF  (1) DRAPE LAP. ABDOM. WITH POUCH 102\" X 122\" X 78\"  (2) DRAPE SHEET 41\" X 58\" SMS  (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD L/F  (5) LAP SPONGE PREWASH XRD LIF  (1 ) DRAPE LASER CAMERA W/EL. 6\" X 96\" LIF  (1) TUBE SUCTION CONNECT. 3/16\" X 12' LIF  (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT)  (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF  (1) SURGICAL DURAPREP SOLUTION 26ML LIF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF    Product Usage:  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-2429-2014",
      "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"
    }
  ]
}