{
  "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": "28 lots; 2620 units (multiple units per lot)",
      "code_info": "Product code 900-620,  28 lots:  111113132  111123276  112010192  112020517  112030733  112041340  112052000  112062500  112072808  112083437  112093729  112114579  112124875  113015455  113025964  113036374  113036444  113068176  113088879  113099447  113109862  131210833  140111241  140211733  140211943  140412839  140513377  140513456",
      "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) MAYO STAND COVER REINFORCED LIF  (1 0) GAUZE SPONGES 4\" X 4\" 16PL Y  (1) TUBE SUCTION CONNECTING X\" X 12' LIF  (1) IMP. STOCKINETTE  (1) SURGICAL BLADE #11 STAINLESS STEEL  (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~  (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF  (2) ELASTIC BANDAGE 6\" X 5yrd LIF  (1) TUR Y SET 81 \"2.1m REGULAR CLAM  (2) NEEDLE HYPODERMIC 18G X 1 ~  (1) TABLE COVER 50\" X 90\" REINFORCED LIF  (5) TOWEL ABSORBENT 15\" X 20\" LIF  (2) DRAPE UTILITY WITH TAPE LIF  (1) DURAPREP SURGICAL SOLUTION 26m I LIF  (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT  (1) Pr. NEUTRALON SURGEON GLOVES #7.5  (1) Pr. NEUTRALON SURGEON GLOVES #8  (1) Pr. NEUTRALON SURGEON GLOVES #8.5  (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS  (10) GAUZE SPONGES 4\" X 4\" 16PLY XRD  (2) STRIPS TAPE  (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF  (1) DRAPE VIDEO CAMERA 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-2338-2014",
      "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"
    }
  ]
}