{
  "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": "18 lots; 882 units (multiple units per lot)",
      "code_info": "Product code 900-1913,  18 lots:  112030657  112041913  112051896  112062467  112114653  112125043  113026231  113036784  113057438  113078284  113088771  113099399  113109766  131110211  131210772  140311185  140412620  140412878",
      "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 PACK -      (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF  (1) DRAPE ENDOSCOPY 1 00\" X 123W' X 77\" WITH TROUGHS  (1) MAYO STAND COVER REINFORCED LIF  (4) TOWEL ABSORBENT 15\" X 20\" LIF  (4) DRAPE UTILITY WITH TAPE LIF  (5) GAUZE SPONGE 2\" X 2\" 4PL Y  (1) CORD LAPAROSCOPY FOOD SWICHING MONOPOLAR  (1) SCALPEL WEIGHTED SAFETY #11  (1) SOLUTION SURGICAL DURAPREP 26ml UF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (2) LITE GLOVE UF  (1) SUTURE BAG FLORAL UF  (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF  (1) UTILITY BOWL 32oz.  (2) SHEET DRAPE 42\" X 57\" SMS  (1) DRAPE LASER CAMERA W/EL 6\" X 96\" LIF  (5) TAPE TEGADERM 2 3/8 X 2 o/. UF  (5) LAP SPONGE PREWASH 18\" X 18\" XRD L/F  (2) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE  (1) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE TOWEL/WRAP    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-2418-2014",
      "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"
    }
  ]
}