{
  "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; 432 units (multiple units per lot)",
      "code_info": "Product code 900-1042, 12 lots:  113026163  113036737  113046994  113057378  113078232  113078669  113089153  113109704  131110065  131110610  140111137  140312045",
      "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": "ARTHROSCOPY PACK -   (1) SURGICAL DURAPREP SOLUTION 26ML LIF  (1) ESMARK BANDAGE  (1 ) ELASTIC BANDAGE 6\" X 5yds LIF  (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG  (1) TUBE SUCTION CONNECTING W X 12' LIF  (1) SHEET EXTREMITY ABS. 125\" X 85\" SMS  (1) DRAPE LASER CAMERA W/EL  (3) TOWELS ABSORBENT 15\" X 20\" LIF  (2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL  (1) BABY BLANKET IMP. POLY ABS. LIF  (1) NEEDLE HYPODERMIC 20G X 1%''  (10) GAUZE SPONGES 4\" X 4\" 16PLY  (1) BLADE SURGICAL #11 CARBON STEEL  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) IMPERVIOUS STOCKINETTE  (1) SHEET DRAPE 42\" X 55\" LIF  (1) SUTURE BAG FLORAL LIF  (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT  (1) MAYO STAND COVER REINFORCED LIF  (2) GOWN IMPERVIOUS REINFORCED SMS LARGE  (4) STRIPS TAPE  (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF  (1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y  (1) GOWN IMPERVIOUS EXTRA REINFORCED 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-2368-2014",
      "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"
    }
  ]
}