{
  "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; 399 units (multiple units per lot)",
      "code_info": "Product code 900-1476, 12 lots:  112030618  112072885  112104097  112114378  112114555  112124949  113015689  113047329  113078255  113088832  113089191  121104357",
      "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": "IMPLANTE DE ORTHOPEDIA -   ( I) CAUTERY T IP POLI SHER LIF   ( I) BAG SUTURE FLORAL LIF  ( I) TUBE SUCTION CONNECT \\14'' X 12' LIF   ( I) BAG GLASSINE LIF  (2) LITE GLOVE LIF   (2) TABLE COVER 50\" X 90\" REINFORCED LIF  ( I) MAYO STAND COVER REINFORCED LIF   (5) TOWEL ABSORBENT 15\" X 20\" LIF  (4) DRAPE UTILITY WITH TAPE LIF   (2) DRAPE SHEET 70\" X I 00\" LIF  (5) LAP SPONGES PRE-WASH 18\" X 18\" XRD L/F   ( I) MAYO TRAY LARGE LIF  ( I) DRAPE TOP WITH ADHESIVE LIF   ( I) SKIN STAPLE 35 WIDE LIF  ( I) BULB SYRINGE 60cc LIF   ( I) UTILITY BOWL 16oz L/F  (2) UTILITY BOWL 32oz L/F   ( I) INCISION DRAPE 23\" X I 7\" L/F  (I) SKIN MARKER WITH RULER LIF   ( I) U-DRAPE 54\" X 72\" W/TAPE SPLIT 6\" X 2 1\" LIF  (2) ABDOMINAL PAD 8\" X 7.5\" L/F   ( I) YANKAUER SUCTION TUBE W/0 VENT L/F  (I) DURAPREP SURGICAL SOLUTION 26ML LIF   ( I) SURGICAL BLADE # 10 STAINLESS STEEL  (I) SPLIT SHEET W/ADH 108\" X 77\"\" STD SMS LIF   ( I) IMP. STOCKINETTE LIF  (I) *Pr. SURGEON NEUTRALON GLOVE #7 ~ LATEX   ( I) *Pr. SURGEON NEUTRALON GLOVE #8 LATEX  (I) *Pr. SURGEON NEUTRALON GLOVE #8 ~ LATEX   (I) SURGEON GOWN REINF. T/WRAP X-LARGE LIF  (2) IMP. GOWN REINFORCED X-LARGE SMS LIF   (I) PENCIL CAUTERY ROCKER SWITCH LIF  (I) SURGICAL BLADE #20 STAINLESS STEEL    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-2394-2014",
      "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"
    }
  ]
}