{
  "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": "3 lots/ 74 units, multiple units per lot",
      "code_info": "Code 900-2719: 3 lots  113047020  113068032  113078729",
      "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": "Shoulder Arthroscopy Pack, code 900-2719, contains:  (1 0) GAUZE SPONGES 4 X 4 12PL Y  (1) COBAN WRAP TAN 4 X 5yds  (3) PAD ABDOMINAL 8 X 7.5  (1) DRESSING 1 X 8 XEROFORM PETROLAT  (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD  (1) NEEDLE HYPODERMIC 18G X 1   (1) NEEDLE SPINAL ANESTH 18G X 3 W  (1) NEEDLE HYPODERMIC 22G X 1 W  (1) SYRINGE 60ML W/O NEEDLE LUER LOCK  (1) BLADE SURG. 11 CARBON STEEL  (1) SKIN MARKER W/RULER  (9) LABELS FOR SKIN MARKERS   (4) PR GLOVE SURG. DERMA PRENE POWDER FREE  (8) TOWELS CLOTH HUCK BLUE  (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21  (1) SHEET 60 X 77 DRAPE REINFORCED  (2) SOLUTION SURGICAL DURAPREP 26ML  (3) TUBE SUCTION CONNECT   (1) TABLE COVER REINFORCED 50 X 90  (1) RULER  (2) GOWN SURGICAL REINFORCED X-LARGE  (1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP  (2) TOWELS ABSORBENT 15 X 20  (2) BAG PLASTIC 6 X 12 2ml  (1) SHOULDER ARTHROSCOPY DRAPE  (1) FILTER STRAW 5 MICRO  (1) UTILITY BOWL 16oz  (1) STOCKINETTE IMPERV 9 X 48  (2) LITE GLOVE  Product Usage:  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-2500-2014",
      "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"
    }
  ]
}