{
  "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": "16 lots; 512 units (multiple units per lot)",
      "code_info": "Product code 900-1062, 16 lots:  109071569  112072765  112083154  113057380  113057684  113057854  113078233  113078670  113089154  113099586  131110151  131110593  131210956  140412452  140513063  140513390",
      "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) VIDEO CAMERA DRAPE 13cm X 244cm LIF  (2) BANDAGE ELASTIC 6\" X 5yrd. LIF  (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT  (1) DURAPREP SURGICAL SOLUTION 26m I LIF  (1) STOCKINETIE IMPERVIOUS  (1) TUBE SUCTION CONNECT. 3/16\" X 12' LIF  (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF  (1) BAG SUTURE FLORAL LIF  (1) BLADE SURGICAL #11 CARBON STEEL  (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF  (1) SYRINGE 30cc SLIP TIP LIF  (1) TABLE COVER 44\" x 90\"  (1) MAYO STAND COVER REINFORCED LIF  (4) TOWELS ABSORBENT 15\" X 20\" LIF  (5) LAP SPONGES PRE-WASH XRD UF  (1) DRAPE SHEET 41 \" x 58\" SMS UF  (1) NEEDLE HYPODERMIC 22G X 1 Y:z  (1) NEEDLE HYPODERMIC 18G X 1 Y:z  (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF  (10) GAUZE SPONGES 4\" X 4\" 16PL Y    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-2371-2014",
      "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"
    }
  ]
}