{
  "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": "39 lots; 600 units (multiple units per lot)",
      "code_info": "Product code 900-1832, 39  lots:  109122842  110010063  110020346  110030645  110051220  110071773  110082195  110092199  110102436  110112622  110122927  111010075  111030627  111041079  111051370  111071782  111082071  111092368  111102709  111113047  111123182  112020420  112030819  112041405  112051890  112072788  112083304  112083409  113026166  113036456  113036733  113047115  113047200  113078282  113088768  113099486  113099587  131010209  140111184",
      "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) TABLE COVER REINFORCED 50\" X 90\"  (1) PRE PAD WITH CUFF  (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill  (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP  (1) MAYO STAND COVER REINFORCED  (1) TUBE SUCTION CONNECT. X\" X 12'  (1) STOCKINETTE IMPERVIOUS 14\" X 48\"  (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT 6\" x 21 \"  (1) SHEET ARTRHOSCOPY \"T\" W/POUCH STD SMS  (1) SUTURE BAG FLORAL  (3) ABSORBENT TOWEL 15\" X 20\"    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-2414-2014",
      "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"
    }
  ]
}