{
  "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/1707 units (multiple units per lot)",
      "code_info": "Product code 900-2193, 28 lots  111082204  111092380  111113084  111123219  111123426  112041379  112083164  112093928  113015445  113026056  113036438  113036728  113046937  113057461  113067867  113078470  113078790  113099287  113109790  131110074  131110499  131210647  131210968  140111415  140311935  140312380  140412834  140513127",
      "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   CONTENTS:\t  (1) \tSUTURE BAG FLORAL  (1) \tUTILITY BOWL 32oz.  (2) \tDRAPE SHEET 70\" X 100\"  (1) \tGOWN SURG REINFORCED XLGE T/WRAP (1) \tNEEDLE SPINAL ANESTH.  18G X 3ST.  (1) \tSTOCKINETTE 6 X 48\"  (1) \tSYRINGE 20cc WITHOUT NEEDLE  LUER LOCK (1) \tSCALPEL WEIGHTED SAFETY# 11  (1) \tBULB SYRINGE 60cc  (1) \tDRAPE BEACH CHAIR SHOULDER  ARTHROSCOPY   (10)  LAP SPONGE PREWASH 18\" X 18\" XRD  (2) \tU-DRAPE  60\" X 70\" WITH TAPE  SPLIT  (2) \tDRAPE SHEET 41\" X 58\" SMS  (1) \t STOCKINETTE IMPERVIOUS 14\" X 48\"   (1) \tTABLE COVER REINFORCED 50\" X 90\"   (1) \t COBAN WRAP TAN 4\" X 5yds  (1) \tTIME OUT BEACON NON WOVEN  (2) \tGOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV   (2) \tMAYO STAND COVER REINFORCED  (1) \tSKIN MARKER INK WITH 8 LABEL  (1) \tTUBE CONNECTING SUCTION X\" X 12'   (1) \t MAYO TRAY SMALL  ( 1) \tCAMERA COVER W/ELAST.      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-2439-2014",
      "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"
    }
  ]
}