{
  "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": "1 lot; 120 units (multiple units per lot)",
      "code_info": "Product code 900-740A,  1 lots:  140312021",
      "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) COVER MAYO STAND REINFORCED UF   (1 0) GAUZE SPONGE 4\" X 4\" 16PL Y XRD LIF  (1) TUBE SUCTION CONNECT ~\" X 12' LIF   (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF  (1) STOCKINETIE IMPERVIOUS 14\" X 48\" LIF   (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F  (1) BLADE SURGICAL# 11 STAINLESS STEEL   (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF  (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF   (1) PAD ABDOMINAL 8\" X 7.5\" LIF  (2) ELASTIC BANDAGE WITH VELCRO 6\" X 5yds LIF   (1) TIME OUT BEACON NON WOVEN LIF  (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F   (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF  (1) COVER TABLE 44\" X 90\" LIF   (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F  (3) TOWELS ABSORBENT 15\" X 20\" LIF   (1) BAG SUTURE FLORAL  (1) SHEET DRAPE 70\" X 1 00\" SMS LIF   (1 0) GAUZE SPONGE 4\" X 4\" 16PL Y  (1) SOLUTION SURGICAL DURAPREP 26ML LIF   (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI  (1) TUR Y SET 81\"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF  (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT 6\" X 21\" UF  (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI  LEVEL Ill LIF    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-2345-2014",
      "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"
    }
  ]
}